MAUDE Adverse Event Report: COOK ENDOSCOPY TRI-TOME PC PROTECTOR; KNS

Catalog Number TRI-25M-P

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our evaluation of the returned device confirmed the report of incorrect cutting wire orientation.During the laboratory analysis, the sphincterotome was advanced through a duodenoscope that is placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter.The catheter exited the endoscope with the cutting wire facing 2 o'clock.The distal end was advanced into the simulated papilla and bowed and the cutting wire oriented in the 1 o'clock position.The sphincterotome catheter was subjected to a close visual examination and a small amount of twisting was observed at the distal end.A discrepancy or anomaly that could have contributed to the reported event was not found during our laboratory analysis of the returned product.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.Prior to distribution, all tri-tome pc protectors are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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.

Event Description

During an endoscopic procedure, the physician used a cook tri-tome pc protector.The device was rotated to three (3) o'clock [incorrect cutting wire orientation] and could not be used.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: TRI-TOME PC PROTECTOR
• Type of Device: KNS
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station road; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station road; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station road; winston-salem, NC 27105
• MDR Report Key: 9516221
• MDR Text Key: 220061305
• Report Number: 1037905-2019-00794
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K901443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2022
• Device Catalogue Number: TRI-25M-P
• Device Lot Number: W4243520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1