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

Catalog Number	TRI-25M
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: an evaluation of the returned device was performed.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 12 o¿clock.After the tip entered the papilla, bowing was attempted.The tip of the sphincterotome would not respond to handle manipulation and could not be bowed.A visual examination of the catheter was performed and it was observed that the drive wire had separated from the cutting wire at the center cannula.Due to the condition of the device, a functional test could not be completed.However, based on the photo provided by the user, the complaint for incorrect cutting wire orientation is confirmed.A further visual examination of the catheter was performed and twisting of the tubing was not observed in the sphincterotome catheter.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.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.¿ 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 advise the user: "upon removing device from package, uncoil and straighten sphincterotome." the user is then instructed: "carefully remove precurved stylet from 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." the device returned had a separation at the center cannula.Separation of the drive wire from the cutting wire can occur if the tip of the device is over flexed.The instructions for use caution the user: ¿do not to over flex or bow the tip beyond 90 degrees, as this may damage or cause cutting wire to break.¿ the instructions for use caution the user: ¿elevator should remain open/down when advancing or retracting sphincterotome.¿ if the elevator of the endoscope is placed in the closed/up position with the sphincterotome inside the accessory channel, this could constrict movement of the drive wire when the handle is manipulated in an attempt to bow the sphincterotome.If added pressure is applied to the handle with the elevator and sphincterotome in this position, this could contribute to drive wire separation from the cutting wire.Prior to distribution, all tri-tome pc triple lumen sphincterotome 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
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook tri-tome pc triple lumen sphincterotome.The device presents mis-orientation [incorrect cutting wire orientation].

• 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: 6411352
• Report Number: 1037905-2017-00110
• Device Sequence Number: 10927327
• Product Code: KNS
• UDI-Device Identifier: 00827002225558
• UDI-Public: (01)00827002225558(17)190811(10)W3752955
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K901443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TRI-25M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/16/2017
• 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: FUJINON DUODENOSCOPE (UNKNOWN MODEL)