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

Model Number	G26826
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
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 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.The channel diameter for the endoscope used during the procedure is unknown.A possible contributing factor to shrink tube detachment is use of the device through an endoscope with a channel diameter that is less than 2.8 mm.The instructions for use advise the user: "refer to package label for minimum channel size required for this device." a possible contributing factor to shrink tube detachment is if the device comes in contact with a sharp object or a burr in the endoscope channel during advancement or removal of the device from the endoscope.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: a review of the complaint history was conducted and this represents an isolated occurrence.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
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook tri-tome pc triple lumen sphincterotome.Per complaint email: "the wire guide port sleeve (black cover over guide wire port) came off of the sphincterotome [while removing the sphincterotome from the endoscope] and was inside channel of the endoscope.Another device was passed down the endoscope, pushing the sleeve out of the endoscope and into the patient's bile duct.The piece was retrieved via forceps.Nothing was left behind, 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: 7035507
• Report Number: 1037905-2017-00685
• Device Sequence Number: 16379901
• Product Code: KNS
• UDI-Device Identifier: 00827002268265
• UDI-Public: (01)00827002268265(17)200814(10)W3902958
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: G26826
• Device Catalogue Number: TRI-25M-SLT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/19/2017
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention