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

Catalog Number	DBF-3.3SM-230SP-20-S
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, a functional test was performed.When the handle was manipulated the forceps cups would open and close intermittently.The handle felt loose during the functional test.A visual inspection of the device was performed and the drive wire was separated from the handle spool.A pair of tweezers were taken and the drive wire was manipulated.The forceps cups would open and close when the drive wire was being manipulated with the tweezers.The forceps were placed down an olympus gif-q20 (2.8 mm channel) endoscope.The endoscope was put in a tortuous path.When the drive wire was manipulated by using the tweezers, the forceps cups would open and close as intended.The device was sent back to the supplier.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 that for the returned device, it was tested for "would not close".During functional testing, it was confirmed that the device would not open or close when manipulated using the handle.Upon disassembly of the handle spool, it was noted that the drive wire had detached from the brass drive wire connector.The drive wire had slipped through the brass drive wire connector eyelets and became free from the handle spool.The screw which fastens the drive wire to the handle spool was found to be loose and there were no visible markings or deflection on the drive wire that usually happens when the screw is tightened correctly into the brass drive wire connector.The reported defect was confirmed for the device.Failure was due to improper torque.The device history records were reviewed and were manufactured in december 2016 and february 2017.One assembly order had no relevant rejects, and one assembly order had relevant defects noted in the records.There were devices rejected during manufacturing or final quality control (fqc) for handle friction defects.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 'forcep cups will open but will not close' issue experienced by the customer was confirmed and the root cause was determined to be failure due to improper torque.The operators and fqc inspectors involved will undergo awareness training.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 forcep is coiled may result in damage to the performance characteristics of the forceps." 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 remote.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 colonoscopy , the physician used a cook captura serrated max forceps-spike.During a biopsy, the operator heard a snap in the handle and the device would no longer close.A new device was opened to complete the procedure.

• Brand Name: CAPTURA SERRATED MAX FORCEPS-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: 6693009
• Report Number: 1037905-2017-00453
• Device Sequence Number: 16460633
• Product Code: FCL
• UDI-Device Identifier: 00827002560550
• UDI-Public: (01)00827002560550(17)200313(10)W3839407
• 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): 07/07/2017

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-3.3SM-230SP-20-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2017
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1