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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion® pre-loaded with acrobat wire guide.It was reported that the physician had a wire guide in placed, put a balloon over it and saw on x-ray that the coating around the wire guide was coming off.It looked to the physician like it was around the 25cm mark where it started tearing off.The physician changed out the wire guide for a single wire guide (not a pre-loaded) or possibly another wire guide of the same kind of 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.
Additional Manufacturer Narrative
Pma/510(k) # k172288.Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.The wire guide did not return with its associated sphincterotome.Our evaluation of the product said to be involved confirmed the report.There is wire guide coating damage near the distal end.Approximately 25.8cm to 26.0cm and 26.5cm to 30.4cm from the distal end is a section of bare core wire.A section of the coating approximately 3.5cm long is frayed and hanging from the wire guide, but the coating is still attached at approximately 30.4cm from the distal end.The frayed portion of covering diverges into two sections at approximately 27.0cm from the distal end.Around the 26.0cm area the coating is damaged and rough.The wire guide is also kinked approximately 168.0cm from the distal end.The device history record for the lot number said to be involved was reviewed.The device history record contains nonconformance that could potentially be related to coating damage.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 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 date of the of the procedure is unknown, however the coating damage was reported on 09/10/2021.This device expired on 09/04/2021 which is three years after the manufacturing date.Out of precaution due to the date reported being close to the expiration date, please reference the expiration date on the front of the device pouch before use.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® pre-loaded with acrobat wire guide 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.Additional comments regarding this report: a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• 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: 12586982
• Report Number: 1037905-2021-00557
• Device Sequence Number: 3078846
• Product Code: KNS
• UDI-Device Identifier: 10827002346939
• UDI-Public: (01)10827002346939(17)210904(10)W4112304
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: 09/04/2021
• Device Model Number: G34693
• Device Catalogue Number: FS-OMNI-ACRO-35-260
• Device Lot Number: W4112304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/06/2021
• 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 ENDOSCOPE, UNKNOWN MODEL