MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEP-SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number	DBF-2.4SL-230SP-40-S
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was observed and the sheath was extended over the link wires and a portion of the forceps cups housing.The sheath also exhibits a folded back appearance.The sheath being extended over this section prevented the forceps cups from opening.Despite the sheath being extended the device would advance and retract from the endoscope.However, the cups would not open.During our evaluation the cups were visually evaluated and potential cup misalignment was observed.The device is being sent back to the supplier for further evaluation where the final determination of cup misalignment will be determined based on the manufacturer¿s specifications.The supplier provided the following evaluation: the device from the reported event was returned in a zip type bag with proof of decontamination.Evaluation of the device determined the following: the returned device was tested for "would not open." during functional testing, with the device coiled in three (3), approximately eight (8) inch loops, it was confirmed that the device would not operate properly when the handle was manipulated.Upon further investigation, it was noted that the coating was over the tip assembly and contacting the forks.The coating is interfering with the movement of the forks.The coating also caused the cups to misalign.The coating was trimmed off of the tip and the device opens and closes with the device coiled in three (3), approximately eight (8) inch loops.The reported defect of unable to open the cups was confirmed.The device was inspected for misaligned cups visually and under magnification.The teeth of the jaws were within specification after the coating was trimmed back.The reported defect of misaligned cups could not be confirmed.The failure was due to the coating interfering with the fork.The root cause is unknown.The device history records were reviewed.The assembly orders for this lot were manufactured in july 2017.Relevant defects were noted in the manufacturing and/or final quality control checklist records.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 supplier provided the following: the "forceps will not open" issue experienced by the customer was confirmed.During functional testing, the device would not operate properly.It was determined that the device would not open due to the coating interfering with the fork.It should be noted that the device was manufactured prior to the implementation of a new trimmer in august 2017.The device was evaluated for misalignment and was determined to be within specification.The root cause of the coating extending over the fork could not be determined.All devices receive a 100% inspection prior to shipment.During manufacturing of the device, the sheath is placed on the coiled catheter prior to the assembly of the forceps cup housing.The instructions for use states: "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." prior to distribution, all captura serrated large forceps 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: 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
In preparation for a procedure, the user selected a cook captura serrated large forcep-spike.The forceps would not open.The device was tested prior to the procedure and would not open.The procedure was completed with another device with no harm to the patient." the device was evaluated on 09/25/2017.The device was found to be potentially misaligned due to the sheath protruding over the cups.

• Brand Name: CAPTURA SERRATED LARGE FORCEP-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: 6954962
• Report Number: 1037905-2017-00644
• Device Sequence Number: 19110475
• Product Code: FCL
• UDI-Device Identifier: 00827002560765
• UDI-Public: (01)00827002560765(17)200814(10)W3904931
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/17/2017

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-230SP-40-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2017
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1