MAUDE Adverse Event Report: COOK ENDOSCOPY DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME; KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES

Model Number	G22143
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: erbe electrosurgical generator, boston scientific jagwire wire guide.Investigation evaluation: our laboratory evaluation of the returned product confirmed the report.During a visual examination of the returned product, a discrepancy or anomaly was observed at the distal end of the device.When bowed, the cutting wire oriented sideways instead of orienting upwards.The cutting wire is intended to orient in the upward direction.Although 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.Prior to distribution, all double lumen wire guided billroth ii 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
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook double lumen wire guided billroth ii sphincterotome.For ercp cannulation and endoscopic sphincterotomy, the physician inserted the billroth ii into the endoscope and tried to access to the ampulla.However, the direction of the tip was in the opposite direction and orientation was not good [incorrect cutting wire orientation].So the physician could not access the ampulla.He used a new one [double lumen wire guided billroth ii sphincterotome] for cannulation.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME
• Common Device Name: KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7747122
• Report Number: 1037905-2018-00344
• Device Sequence Number: 16473766
• Product Code: KNS
• UDI-Device Identifier: 00827002221437
• UDI-Public: (01)00827002221437(17)190719(10)W3747090
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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 Expiration Date: 07/19/2019
• Device Model Number: G22143
• Device Catalogue Number: PTG-20-6-BII-NG
• Device Lot Number: W3747090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1