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

Catalog Number	DBF-2.4SN-230SP-40-S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2017
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.However, we can confirm that the cups are visually misaligned.The device was returned and no kinks or bends were noted.A functional test was performed by manipulating the handle and cups would open and close as intended.When the forceps cups were in the closed position, the cups would slightly open intermittently without any handle manipulation, but the cups would fully close with pressure applied to the handle.The device was not placed down an endoscope because of the misalignment being severe.While visually observing the cups for misalignment, it was noted that one of the cups is pointing inward while in the closed position.The cup that is pointing inward appears as if it could be twisted.When the cups are in the open position, the link wires are bowing outward from the forceps cups housing.The device will be sent to the supplier for further evaluation.The supplier provided the following response: one device was returned in a zip type bag with proof of decontamination.For the returned device, the device was tested for ¿would not close.".During functional testing, with the device coiled in three (3), eight (8) inch loops, it was not confirmed that the device would not operate properly when the handle was manipulated.The device opened and closed as intended.The device was functionally evaluated for ¿cup observed pointing inward." the cups opened and closed as intended, but the observed failure was confirmed.No root cause was determined for the cup pointing inward.The device was also evaluated for ¿cup misalignment." under magnification, the visible material thickness for the device measured greater than the specification.Measured in two places under magnification, the distance between fork arms for the device are relatively parallel and satisfy the maximum allowable dimension.The device was also disassembled and evaluated per request.The link wires functioned correctly and opened the cups, but upon full attention of the handle, the link wires bowed outward.Upon further investigation of the device, the solder joint was determined to be intact.The device appears to have experienced some mechanical force causing the cup to bend.The cup bending potentially occurred once the device was released from the supplier.During the lab evaluation an attempt was made to replicate the condition of the device, but the attempt was not successful.The cups were evaluated and the inspection report of the cups was reviewed and there were no non-conformances associated with this lot.The root cause for the cup pointing inward is unknown and the root cause for ¿bowing¿ of link wires is unknown.The device history records for the packaging work order were reviewed.The assembly order for this lot was manufactured in august 2017.No relevant defects were noted in the 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 reported defect of cup misalignment was confirmed.The cause of the cup misalignment is unknown.Each device receives a 100% inspection prior to release and shipment.Prior to distribution, all captura serrated forceps with spike are subjected to a visual inspection to ensure device integrity.The device goes through several different inspections in manufacturing, final quality control, and packaging departments prior to leaving the facility in an effort to ensure cup alignment.Therefore, it is unknown how or at what point the cups became misaligned at the distal end.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 biopsy procedure, the physician used a cook captura serrated forceps with spike.The device was broken.It appears that the forceps would not close.The device was received for evaluation on (b)(6) 2017.It was found that the cups were misaligned.

• Brand Name: CAPTURA SERRATED FORCEPS WITH 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: 7119014
• Report Number: 1037905-2017-00755
• Device Sequence Number: 19206301
• Product Code: FCL
• UDI-Device Identifier: 00827002561335
• UDI-Public: (01)00827002561335(17)200830(10)W3912001
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/14/2017

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-2.4SN-230SP-40-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2017
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2017
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1