MAUDE Adverse Event Report: COOK ENDOSCOPY MINITOME PRECURVED DOUBLE LUMEN SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pancreatitis (4481)

Event Date 05/01/2009

Event Type  Injury  

Event Description

Cook endoscopy was notified of this event via a clinical literature article involving the use of minitome precurved double lumen sphincterotomes.This article was published in 2021.It was reported that pep [post-ercp pancreatitis] occurred in 11 (12.6%) patients and was always managed conservatively with brief hospitalization.It was not published if a section of the device remained inside the patient¿s body.It was published that the patients did require additional hospitalization due to this occurrence.

Manufacturer Narrative

A product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.We could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.A device failure was not reported.The ifu lists the potential complications: "potential complications associated with ercp include, but are not limited to: pancreatitis, cholangitis, aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest." the mt product line was obsoleted by cook medical in 2018.These sphincterotomes have a three year expiration date, therefore all devices suspected to be used in this occurrence were manufactured and distributed by cook medical are beyond their expected life.Prior to distribution, all minitome precurved double lumen sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity.Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.M.C.Conti bellocchi, s.F.Crino, f.Pin et al., reappraisal of factors impacting the cannulation rate and clinical efficacy of endoscopic minor papilla sphincterotomy.Https://doi.Org/10.1016/j.Pan.2021.01.019.

• Brand Name: MINITOME PRECURVED DOUBLE LUMEN SPHINCTEROTOME
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 12712739
• MDR Text Key: 283768829
• Report Number: 1037905-2021-00592
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUODENOSCOPE - OLYMPUS TJF 160
• Patient Outcome(s): Required Intervention