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

Catalog Number	TRI-20M
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: 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.The evaluation of the photo provided from the customer shows incorrect orientation of a sphincterotome in the endoscopic view.However, it is unknown which device (device 1, lot w3717533, mdr report number 1037905-2016-00379, or device 2, lot w3748130, mdr report number 1037905-2016-00380) is pictured.Without return of the complaint device, further investigation cannot be completed.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: 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.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 state: "upon removing device from package, uncoil and straighten sphincterotome.Carefully remove precurved stylet from cannulating tip.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.¿ 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." prior to distribution, all tri-tome pc triple lumen 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 or Problem Description
As reported to customer relations: "during an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook tri-tome pc triple lumen sphincterotome.As they bowed the sphincterotome, it bowed to the left [incorrect cutting wire orientation].It was removed and they used another sphincterotome which had the same results [second device also had incorrect cutting wire orientation] (see mdr report number 1037905-2016-00380).They used a different cook sphincterotome to continue the procedure with no further complications.There was no harm to the patient.".

• Brand Name: TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
• 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: 5980722
• Report Number: 1037905-2016-00379
• Device Sequence Number: 13853665
• Product Code: KNS
• UDI-Device Identifier: 00827002225848
• UDI-Public: (01)00827002225848(17)190512(10)W3717533
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K901443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2016

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 Catalogue Number: TRI-20M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2016
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2016
• Initial Report FDA Received Date: 09/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS ERCP ENDOSCOPE