Evidence map›Paper›PMID 37969167›Full record

ArticleEndoscopic ultrasound

Device malfunctions with use of EUS-guided fine-needle biopsy devices: Analysis of the MAUDE database.

Achintya D Singh, Deepak Madhu, Mythili Menon Pathiyil, Daryl Ramai, Babu P Mohan, Bhavesh Shah, Douglas G Adler

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Endoscopic ultrasound. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 2 countries.

Achintya D SinghGastroenterology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA.
Deepak MadhuGastroenterology, Lisie Institute of Gastroenterology, Lisie Hospital, Kochi, Ernakulam, India.
Mythili Menon PathiyilInternal Medicine, Saint Vincent Hospital, Worcester, MA USA.
Daryl RamaiGastroenterology and Hepatology, University of Utah Health, Salt Lake City, UT, USA.
Babu P MohanGastroenterology and Hepatology, University of Utah Health, Salt Lake City, UT, USA.
Bhavesh ShahGastroenterology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA.
Douglas G AdlerGastroenterology, Center for Advanced Therapeutic Endoscopy, Denver, CO, USA.
University of Utah · USCase Western Reserve University · USLourdes Hospital · INMetroHealth Medical Center · USSaint Vincent Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The safety of endoscopic ultrasound-guided tissue acquisition through fine-needle biopsy devices is well-established in clinical trials. The real-world experience of using these devices is not known. The authors analyzed the postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to answer this question. Methods: The Food and Drug Administration MAUDE database from January 2012 to June 2022 was accessed to evaluate for device malfunctions and patient-related adverse consequences of these malfunctions. Results: There were 344 device-related issues. Most issues were due to detachment or breakage of the device ( Conclusion: The fine-needle biopsy devices can be associated with needle breakage and bending; these adverse events were not previously reported. Needle breakages can result in a retained foreign body that may require additional procedures including surgery. These real-world findings from the MAUDE database may inform clinical decisions and help improve clinical outcomes.

Indexed as

Biopsy needlesEndoscopic ultrasoundFine-needle biopsyProcedure related adverse events

Identifiers

PMID37969167
PMCPMC10631607
OpenAlexW4388050734

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.