MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number	FS-OMNI-ACRO-35-205
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-health care professional 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 sub assembly device history record for the wire guide said to be involved was reviewed.A discrepancy or anomaly was not observed.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 instructions for use instruct the user to do the following: "for best results, wire guide should be kept wet." failure to flush the wire guide can result in damage to the wire guide.The instructions for use precaution the user that this product is not compatible with metal tip devices."if preloaded, use of wire guide with metal tip ercp devices may result in damage to external coating and/or tip of wire guide." the reported observation can occur if the wire guide was used with an incompatible accessory device.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all fusion preloaded with acrobat wire guide sphincterotomes are subjected to a visual inspection 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 fusion pre-loaded with acrobat wire guide sphincterotomes.The coating of the wire guide was peeling off [coating damage] during use.According to the customer, the product [wire guide] did not rip off [while] in contact with the elevator of the duodenoscope.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.
Additional Manufacturer Narrative
Investigation evaluation: two products said to be involved were returned in opened pouches from the lot number provided in the report.The labels match the products returned.Device one (1) - the sphincterotome associated with this device was not included in the return of the device.Our laboratory evaluation of the product said to be involved confirmed the report.A visual examination of the returned wire guide was performed.Bare core wire was observed between 13.4 cm and 20.1 cm from the distal end.Wire guide coating had peeled and folded over itself between 6.7 cm and 13.4 cm from the distal end.Due to the condition of the returned device it cannot be determined if any section of the coating is missing.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.Device two (2) - the sphincterotome associated with this device was not included in the return of the device.Our laboratory evaluation of the product said to be involved confirmed the report.A visual examination of the returned wire guide was performed.A kink was observed in the wire guide approximately 18 cm from the distal end.Bare core wire was exposed between 18.5 cm and 19 cm from the distal end and wire guide coating had peeled and folded over itself between 16.4 cm and 18.5 cm from the distal end.Wire guide coating had folded over and bunched up between 24.3 cm and 25.4 cm from the distal end.Bare core wire was exposed between 25.4 cm and 26.8 cm from the distal end.Due to the condition of the returned device it cannot be determined if any section of the coating is missing.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The sub assembly device history record for the wire guide said to be involved was reviewed.A discrepancy or anomaly was not observed.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.The instructions for use instruct the user to do the following: "for best results, wire guide should be kept wet." failure to flush the wire guide can result in damage to the wire guide.The instructions for use precaution the user that this product is not compatible with metal tip devices."if preloaded, use of wire guide with metal tip ercp devices may result in damage to external coating and/or tip of wire guide." the reported observation can occur if the wire guide was used with an incompatible accessory device.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all fusion preloaded with acrobat wire guide sphincterotomes are subjected to a visual inspection 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 fusion pre-loaded with acrobat wire guide sphincterotomes.The coating of the wire guide was peeling off [coating damage] during use.According to the customer, the product [wire guide] did not rip off [while] in contact with the elevator of the duodenoscope.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: FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE
• 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: 7839237
• Report Number: 1037905-2018-00385
• Device Sequence Number: 19420079
• Product Code: KNS
• UDI-Device Identifier: 10827002346014
• UDI-Public: (01)10827002346014(17)201220(10)W4008530
• Combination Product (Y/N): N
• PMA/510(K) Number: K052051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2018

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: 12/20/2020
• Device Catalogue Number: FS-OMNI-ACRO-35-205
• Device Lot Number: W4008530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 09/27/2018
• 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 DUODENOSCOPE, UNKNOWN MODEL