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
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued from concomitant products : cook fusion quattro extraction balloon, fs-qeb-a.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 subassembly device history record for the wire guide subassembly lot number said to be involved was reviewed.Non-conformances were observed that could be related to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to 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: 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 damage.Prior to distribution, all fusion® pre-loaded with acrobat wire guides are subjected to a visual inspection and functional test 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 a cook fusion pre-loaded with acrobat wire guide sphincterotome.The wire coating stripped off from the core.The guide wire coating delaminated [peeled] during the procedure and needed replacing.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.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion pre-loaded with acrobat wire guide sphincterotome.The wire coating stripped off from the core.The guide wire coating delaminated [peeled] during the procedure and needed replacing.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
Concomitant medical products: cook fusion quattro extraction balloon, fs-qeb-a.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.There was wire guide coating damage near the distal end.The distal 13.5 cm has numerous kinks and some slight discoloration of the silver markings.At 26.7 cm to 28.2 cm from the distal end, was a section of bare core wire.At 28.2 cm, there was a piece of coating that has frayed and was hanging off of the wire guide.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 subassembly device history record for the wire guide subassembly lot number said to be involved was reviewed.Non-conformances were observed that could be related to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to 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.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 damage.Prior to distribution, all fusion pre-loaded with acrobat wire guide sphincterotomes are subjected to a visual inspection and functional test 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.

• 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: 8170554
• Report Number: 1037905-2018-00593
• Device Sequence Number: 13817661
• Product Code: KNS
• UDI-Device Identifier: 10827002346939
• UDI-Public: (01)10827002346939(17)210910(10)W4113419
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2021
• Device Catalogue Number: FS-OMNI-ACRO-35-260
• Device Lot Number: W4113419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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: FUJINON DUODENOSCOPE, UNKNOWN MODEL