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

Model Number G49197

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned without the precurved stylet in the distal end of the device.A visual examination of the distal end of the device shows that the cutting wire is twisted [pointed in the wrong direction].Although the anchor remains secure in the catheter lumen, it has moved proximally by approximately 1 mm.The distal end does not represent the shape at the time of manufacture.The device goes through several different inspections in manufacturing, final quality control, and packaging departments prior to leaving the facility in an effort to ensure proper orientation.Therefore, it is unknown how or at what point the cutting wire and catheter became twisted at the distal end.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 product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.The description of event states: "the operator thinks the 1 o¿clock sphincterotome [orientation] is not safe to use in operation", however, appropriate orientation is approximately 11:00 - 1:00 o'clock.Therefore, this device was within specification based on the user's comment.Improper cutting wire orientation can occur if the distal end of the catheter is shaped manually.This sphincterotome catheter is pre-curved and is provided with a pre-curved 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.¿ other factors that can contribute to improper cutting wire orientation include manipulating the handle with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use contain the following comment: "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." movement of the anchor proximally can occur if the sphincterotome catheter is placed in a tightly coiled position.The instructions for use advise the user with the following statement: ¿upon removing device from package, uncoil and straighten sphincterotome.Carefully remove precurved stylet from cannulating tip.¿ the instructions for use also caution the user: "do not over flex or bow tip beyond 90 degrees." prior to distribution, all tri-tome pc protector sphincterotomes 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.

Event Description

In preparation for a procedure, the user selected a cook tri-tome pc protector sphincterotome.The cutting wire has a little deviation, pointing at the 1 o'clock direction, which might cause difficulty in passing the endoscope after injecting normal saline into wire guide port to confirm it is available.The operation was completed with another cook tri-tome pc protector sphincterotome.The following additional information was received on 10/19/17: the marketing activities promote the sphincterotome to point around 12 o¿clock.The operator is used to using the sphincterotome that points around 12 o¿clock, which is safe to do operation.The operator thinks the 1 o¿clock sphincterotome is not safe to use in operation.There was no reportable information at this time as the information indicated the device was within specification.The device was evaluated on 11/03/17 and it was observed the end of the sphincterotome was twisted [pointed in wrong direction].

• Brand Name: TRI-TOME PC PROTECTOR
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7063175
• MDR Text Key: 93721969
• Report Number: 1037905-2017-00718
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002491977
• UDI-Public: (01)00827002491977(17)200112(10)W3816266
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K901443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G49197
• Device Catalogue Number: TRI-25M-P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2017
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• 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
• Patient Age: 57 YR
• Patient Weight: 74