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	Failure to Align (2522)
Health Effect - Clinical Codes	Tissue Damage (2104); No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2017
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 device, the forceps were advanced down an olympus 2.8 mm channel endoscope.When the handle was manipulated, the forceps cups would open and close as intended.A functional test was performed by taking a biopsy sample of simulated tissue.The forceps would take a bite of the simulated tissue as expected.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.Investigation conclusion: the product was returned to the approved supplier for evaluation and the investigation is ongoing.Once additional information has been received a follow-up emdr report will be provided.
Event or Problem Description
During a colonoscopy, the physician used five (5) captura serrated large forcep-no spike.The forceps are tearing the tissue.
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The user only sent back one device for evaluation.During the evaluation of the device, the forceps were advanced down an olympus 2.8 mm channel endoscope.When the handle was manipulated, the forceps cups would open and close as intended.A functional test was performed by taking a biopsy sample of simulated tissue.The forceps would take a bite of the simulated tissue as expected.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: one device from the reported event was returned in a zip type bag with proof of decontamination.Evaluation of the returned device was performed.During functional testing, with the device coiled in three (3), approximately eight (8) inch loops, it was confirmed that the device would operate properly when the handle was manipulated.The device opens and closes.Upon further investigation the device was inserted in to a colonoscope.In a torturous path configuration the device opened and closed as intended.The device was visually inspected under magnification for misaligned cups.The cups are misaligned more than the thickness of the cup material.The reported defect of "cup misalignment " is confirmed.The root cause of the misaligned cups was improper alignment of the link wires.The device history records were reviewed.The assembly orders for this lot were manufactured in may 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 tearing tissue" issue experienced by the customer was confirmed.The root cause was determined to be misaligned cups, which resulted from improper alignment of the link wires.Prior to distribution, all captura serrated large forcep - no spike 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.

• 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: 6921727
• Report Number: 1037905-2017-00626
• Device Sequence Number: 19045730
• Product Code: FCL
• UDI-Device Identifier: 00827002560598
• UDI-Public: (01)00827002560598(17)200609(10)W3876591
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/31/2017

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: 07/19/2017
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1