MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEP-NO SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number	DBF-2.4SL-230-40-S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.We can confirm that the device was cut.The device was received cut and the forceps housing was not returned for evaluation.The distal end where the device was cut displayed the appearance of a cut.The drive wire cable was 160.3 cm in length; the drive wire length should be approximately 230 cm, so the distal 70 cm was not returned.The handle moved freely when manipulated and the handle wire was severely bent.Due to the condition of the returned device a full evaluation could not be performed.The device was sent back to the supplier for further evaluation.The supplier provided the following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.Evaluation of the device determined functional testing could not be performed to evaluate for "would not close" due to severe damage to the device.The catheter exhibited a cut and was severed approximately 7.5 cm from distal end of the handle.The drive wire protruded approximately 0.7 cm from the severed cut in distal end.The drive wire cable was also severely damaged and measured approximately 160 cm.Due to the condition of the damaged device, functional testing could not be performed and the reported defect could not be performed.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: the "unable to close" issue experienced by the customer could not be confirmed and the root cause could not be determined.No corrective action will be taken at this time for this issue.The instructions for use state the following in regards to product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps." the instructions for use cautions the user: "if forceps fail to close, slowly pull against channel opening.Remove endoscope and forceps as a unit, then manually close cups and withdraw forceps from endoscope." prior to distribution, all captura biopsy forceps are subjected to a visual inspection and functional test to ensure proper workability.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
During a colonoscopy, the physician used a cook captura serrated large forceps-no spike.The forceps were pre-tested and when they got to the targeted site they were unable to close the forceps once it was opened.They had to cut the forceps, distal of the forceps handle, to remove the device from the endoscope.They completed the procedure with another device.

• Brand Name: CAPTURA SERRATED LARGE FORCEP-NO SPIKE
• Common Device Name: FCL, FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6664022
• Report Number: 1037905-2017-00427
• Device Sequence Number: 13967916
• Product Code: FCL
• UDI-Device Identifier: 00827002560598
• UDI-Public: (01)00827002560598(17)200427(10)W3857824
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2017

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 Catalogue Number: DBF-2.4SL-230-40-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/30/2017
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1