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

Model Number	G34693
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our photo evaluation of the product said to be involved confirmed the report.There is wire guide coating damage near the distal end, and a section of core wire was exposed.The measurement markings are not visible at the distal end, so the location of the damage cannot be approximated from the photo.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: 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.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.Another possible contributing factor to wire guide damage is if the wire guide lumen is not flushed prior to wire guide advancement.The instructions for use also states, "flush endoscope accessory channel and/or lumen of device with sterile water, then insert wire guide floppy end first." prior to distribution, all fusion pre-loaded 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) procedure, the physician used a cook fusion® pre-loaded with acrobat wire guide sphincterotome for a pancreatic cancer metal stent case.The wire that was preloaded in the sphincterotome stripped when a balloon was used during first exchange.The wire stripped so badly it grabbed onto the balloon catheter and lost wire guide cannulation.The procedure was completed with another device.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: 11274131
• Report Number: 1037905-2021-00041
• Device Sequence Number: 3543073
• Product Code: KNS
• UDI-Device Identifier: 10827002346939
• UDI-Public: (01)10827002346939(17)230619(10)W4356708
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K052051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: 06/19/2023
• Device Model Number: G34693
• Device Catalogue Number: FS-OMNI-ACRO-35-260
• Device Lot Number: W4356708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1