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

Catalog Number	DBF-2.4SL-230-S
Medical Device Problem Codes	Solder Joint Fracture (2324); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a laboratory evaluation of the product, a functional test was performed.The handle of the device was manipulated to inspect if the forceps cups would open and close.The forceps cups would not close when the handle was manipulated.An attempt was made to close the forceps cups by hand, but was unsuccessful.Due to the forceps cups not being able to close, the device was not placed down an endoscope for additional functional testing.The device was sent 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.The returned device was tested for "would not close." during functional testing, with the device coiled in three (3), eight inch loops, it was confirmed that the device would not operate properly when the handle was manipulated.The device would open but would not close as intended.Upon further investigation and disassembly of the device tip, it was noted that the device solder connection was broken.The reported defect of "would not close" was confirmed.The device history records were reviewed and this lot was found to be manufactured in march and april 2017.Relevant defects were noted in the manufacturing records and the final quality control checklist.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 cups will open but will not close" issue was confirmed and the root was determined to be a broken solder joint.The supplier is currently working on improvements to create a more robust soldering process to prevent solder joints from breaking.In addition, a corrective action has been initiated to reduce occurrences of cups open and close difficulties for disposable forceps.The product said to be involved is included in the scope of the corrective actions.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 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.A corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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 forcep - no spike.They wanted to take biopsies.After advancing the forceps out of the working channel, it was not possible to open the cups.The device was evaluated on 12/14/2017 and the cups were found to open, but not close upon handle manipulation.

• 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: 7171605
• Report Number: 1037905-2018-00010
• Device Sequence Number: 1485720
• Product Code: FCL
• UDI-Device Identifier: 00827002536333
• UDI-Public: (01)00827002536333(17)200427(10)W3857823
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2018

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-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2017
• Device Age: 7 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1