MAUDE Adverse Event Report: COOK ENDOSCOPY DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number	PTG-20-6-BII-NG
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: during a visual examination of the first returned product, a discrepancy or anomaly was not observed.The handle was manipulated and the tip of the catheter appeared to bow correctly.The cutting wire was intact and fully attached to the catheter tip.Twisting was not observed at the distal end of the catheter.During a visual examination of the second returned product, a discrepancy or anomaly was not observed.The handle was manipulated and the tip of the catheter appeared to bow correctly.The cutting wire was intact and fully attached to the catheter tip.Twisting was not observed at the distal end of the catheter.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 handle is manipulated with the catheter in a coiled position.The instructions for use advise the user to "uncoil and straighten sphincterotome" upon removing the device from the packaging.The instructions for use contain the following comment: "do not exercise handle while device is coiled, as this may result in damage to sphincterotome and render it inoperable." prior to distribution, all double lumen wire guided billroth ii 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 two (2) cook double lumen wire guided billroth ii sphincterotomes.The cutting wire pointed in the wrong direction, at the 12 o'clock position.The cutting wire of the sphincterotome was oriented to the wrong side, opposite to the correct side [for billroth ii anatomy].

• Brand Name: DOUBLE LUMEN WIRE GUIDED BILLROTH II 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: 5990197
• Report Number: 1037905-2016-00385
• Device Sequence Number: 1451536
• Product Code: KNS
• UDI-Device Identifier: 00827002221437
• UDI-Public: (01)00827002221437(17)181026(10)W3633197
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K901443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2016

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: PTG-20-6-BII-NG
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/07/2016
• Device Age: 11 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2016
• Initial Report FDA Received Date: 09/30/2016
• 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 GIF-Q165 GASTROSCOPE