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

Model Number	G49197
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Investigation evaluation: an evaluation of the returned device confirmed the report.During our laboratory analysis, the sphincterotome catheter was subjected to a close visual examination and twisting of the tubing was observed at the distal end.The cutting wire was not oriented in the upward direction.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: twisting of the tubing was confirmed at the distal end.The cause of the twisting is unknown.The 3d shaping wire was not returned with the device, it is unknown when the twisting occurred.Proper orientation is determined relative to the papilla within an endoscope, the user's observation occurred prior to patient contact.The instructions for use include the following system preparation: "upon removing device from package, uncoil and straighten sphincterotome.Carefully remove precurved stylet from cannulating tip.Note: do not apply manual pressure to tip or cutting wire of sphincterotome to influence orientation, as this may result in damage to device.Note: do not exercise handle while device is coiled or precurved stylet is in place as this may cause damage to sphincterotome and render it inoperable." 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 or Problem Description
In preparation for a procedure, the physician chose a cook tri-tome pc protector.The user opened the package and found out the cutting wire orientation was deviated [pointed in the wrong direction].It was not used on patient.This occurred prior to patient contact; there was no impact to the patient.

• 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: 9280491
• Report Number: 1037905-2019-00671
• Device Sequence Number: 2184248
• Product Code: KNS
• UDI-Device Identifier: 00827002491977
• UDI-Public: (01)00827002491977(17)211213(10)W4157100
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K901443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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 Expiration Date: 12/13/2021
• Device Model Number: G49197
• Device Catalogue Number: TRI-25M-P
• Device Lot Number: W4157100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1