MAUDE Adverse Event Report: COOK ENDOSCOPY TRI-TOME PC PROTECTOR; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G49197
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant product(s): erbe electrosurgical generator.Investigation evaluation: an evaluation of the returned device confirmed the report on incorrect cutting wire orientation.During our 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 (model number olympus tjf-160v).The catheter exited the endoscope with the cutting wire facing 3 o¿clock.The device was then bowed and the cutting wire was facing 3 o'clock (appropriate orientation is approximately 11:00 - 1:00 o'clock).The sphincterotome catheter was subjected to a close visual examination and twisting of the tubing was observed at the distal end.A discrepancy or anomaly that could have contributed to the reported event was not observed 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: the additional information provided indicated that the distal end of the catheter was formed manually.This may have contributed to the reported observation.Improper cutting wire orientation can occur if the distal end of the catheter is shaped manually.This sphincterotome catheter is precurved and is provided with a precurved stylet in the distal tip of the catheter.This obviates the need for manual formation.The instructions for use contain the following comment: ¿note: do not apply manual pressure to tip or cutting wire of sphincterotome to influence orientation, as this may result in damage to device.¿ 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: 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.Additional comments regarding this report: based on the information provided that the catheter was formed manually, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) and endoscopic sphincterotomy (est), the physician used a cook tri-tome pc protector sphincterotome (tri-35m-p).The nurse unwraped the tri-25m-p and checked whether there was a problem or not.There was no problem.The physician inserted the tri-25m-p in the endoscope and accessed near the ampulla, but the tip of tri-25m-p was not pointing in the fitness direction (11'o clock) [incorrect cutting wire orientation].A new one was used.The additional questions answered indicates that the direction was not at 11 o'clock but at 1-2 o'clock.

• Brand Name: TRI-TOME PC PROTECTOR
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7300262
• Report Number: 1037905-2018-00077
• Device Sequence Number: 957423
• Product Code: KNS
• UDI-Device Identifier: 00827002491977
• UDI-Public: (01)00827002491977(17)200623(10)W3880923
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K901443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G49197
• Device Catalogue Number: TRI-25M-P
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/25/2018
• Device Age: 7 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1