MAUDE Adverse Event Report: COOK ENDOSCOPY UTS PRECURVED ULTRA TAPER SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number	UTS-20M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our evaluation of the returned device confirmed the report.The cutting wire has broken near the distal end.Due to the break in the cutting wire, the sphincterotome will not respond to handle manipulation and is no longer operational.No portion of the cutting wire is visible exiting the proximal lumen.A gap between the cutting wire break was noted, approximately 15 mm, resulting in a portion of the cutting wire detached from 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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Cutting wire breakage can also occur if the cutting wire makes contact with the endoscope when electrosurgical current is applied to perform the sphincterotomy.The instructions for use caution the user to ensure the cutting wire is completely out of the endoscope when applying electrosurgical current.The instructions caution the user that contact of the cutting wire with the endoscope could result in breakage of the cutting wire.If the sphincterotome is used with excessive electrosurgical current settings provided by the electrosurgical unit, this can contribute to cutting wire breakage.The instructions for use for this sphincterotome direct the user to verify desired settings by following the electrosurgical unit manufacturer¿s instructions.Prior to distribution, all uts precurved ultra taper sphincterotome are subjected to a visual inspection and functional test to ensure device integrity.The functional test includes bowing the sphincterotome to ensure the distal end responds to handle manipulation.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 unusual occurrence.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
The cutting wire broke during the procedure.It is unknown as to if this was prior to, during, or after application of current.On (b)(6) 2016, the device was returned for evaluation.The cutting wire was broken and a portion was missing.The user facility confirmed that no portion of the device remained in the patient.

• Brand Name: UTS PRECURVED ULTRA TAPER 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: 5483567
• Report Number: 1037905-2016-00049
• Device Sequence Number: 401589
• Product Code: KNS
• UDI-Device Identifier: 00827002224292
• UDI-Public: (01)00827002224292(17)181016(10)W3633196
• 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): 02/11/2016

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: UTS-20M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/22/2015
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2016
• Initial Report FDA Received Date: 03/07/2016
• 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 ENDOSCOPE, UNKNOWN MODEL