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-35-260

Device Problems Material Frayed (1262); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: erbe electrosurgical generator, cook zimmon biliary stent, zso-7-5. Investigation evaluation: our evaluation of the product said to be involved confirmed the report. There is wire guide coating damage near the distal end. A section between 8. 5 cm and 15. 6 cm from the distal end has bare core wire exposed. The wire guide coating has folded over on itself toward the distal end in a section approximately 2. 8 cm and 8. 5 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. The sphincterotome associated with this device was not included in the return of the device. A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis. A review of the wire guide subassembly device history record was performed. Nonconformities that could be related to the observation reported by the user were found in the wire guide subassembly device history record. The inspection process would have removed any products having this nonconformance prior to distribution. Therefore, a discrepancy or anomaly was not observed with the product that was released for distribution. 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: "note: for best results, this wire guide should be kept wet. " this activity will aid in optimal performance of 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 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 Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion pre-loaded with acrobat wire guide sphincterotome. The coating stripped off the pre-loaded wire guide approximately 15 cm from the end of the wire. The case was proceeding normally until the customer tried to place a plastic stent over the guide wire and it became clear that the coating had sheared off.

• Brand Name: FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7525976
• MDR Text Key: 108738433
• Report Number: 1037905-2018-00209
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: FS-OMNI-ACRO-35-260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2018
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial