MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G56103
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The wire guide was returned without the associated sphincterotome.During a visual examination of the wire guide, damage was observed at the distal end.A section of wire guide coating approximately 4.3 cm long detached from the distal end of the wire guide causing the coil spring to unravel and exposing bare core wire.The detached portion of wire guide coating is hanging from the unraveled coil spring at the distal tip of the device.Due to the condition of the returned device it cannot be determined if any sections of the coating are missing.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot number said to be involved was reviewed.The device history record contains nonconformances that could potentially be related to wire guide damage near the distal end.The device goes through various inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.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 prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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.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 omni-tome pre-loaded 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: a review of the complaint history was conducted.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
Prior to an endoscopic retrograde cholangiopancreatography (ercp) the physician selected a fusion omni-tome pre-loaded sphincterotome.The device came with a frayed wire.They were able to use the sphincterotome portion of the device, but had to replace the pre-loaded sphincterotome wire guide.The wire guide of the device was received for evaluation on 20-aug-2020.A portion of the black coating at the tip has come off.It is still attached to the core wire but the core wire is unraveled [subject of the report].This occurred prior to patient contact.There was no impact to the patient.

• Brand Name: FUSION OMNI-TOME PRE-LOADED 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: 10488823
• Report Number: 1037905-2020-00356
• Device Sequence Number: 19471063
• Product Code: KNS
• UDI-Device Identifier: 00827002561038
• UDI-Public: (01)00827002561038(17)230702(10)W4360861
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K052051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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: 07/02/2023
• Device Model Number: G56103
• Device Catalogue Number: FS-OMNI-21-260
• Device Lot Number: W4360861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1