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 Consequences Or Impact To Patient (2199)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.Our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, the device was functionally tested.When the handle of the device was manipulated the forceps cups will open, but they will not close.Several attempts were made to close the forceps cups, but they were unsuccessful.The device was then placed down an olympus gif-q20 (2.8 mm channel) endoscope.The endoscope was put in a torturous path.When the handle was manipulated the device would open, but the cups would not close.This device and twelve (12) sealed devices were sent to the supplier for further evaluation.The supplier provided the following evaluation: one (1) device from the reported event was returned in a zip type bag with proof of decontamination.Additionally, twelve (12) devices in sealed pouches were returned for evaluation.Evaluation of the device that was tested before the procedure determined the device was tested for "would not close".During functional testing, with the device coiled in three (3), 8" loops, it was confirmed that the device would not operate properly when the handle was manipulated.The device opens but does not close.Upon further investigation and disassembly of the device tip, it was noted that the device has a butt joint that has broken at the solder connection.The reported defect of "would not close" was confirmed.Failure was due to a broken solder joint.For the twelve (12) additional devices that were returned for evaluation, each device was tested for "would not close".During functional testing, with the devices coiled in three (3), 8" loops, it was not confirmed that the devices would not operate properly when the handle was manipulated.The devices opened and closed properly.The reported defect of "would not close" was not confirmed.The device history records for packaging work order were reviewed.Packaging work order consisted of one assembly order manufactured april 2017.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 "forceps would not close" issue experienced by the customer was confirmed for the device tested before the procedure, and the root cause was determined to be a broken solder joint.They are 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 instruction 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 forceps 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 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
In preparation for a procedure, the physician selected a cook captura serrated forceps with spike.The forceps would not open when testing before the procedure.The device was evaluated on 07/26/2017.It would open, but would not close.

• 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: 6798084
• Report Number: 1037905-2017-00537
• Device Sequence Number: 18965694
• Product Code: FCL
• UDI-Device Identifier: 00827002561335
• UDI-Public: (01)00827002561335(17)200501(10)W3858388
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: 07/06/2017
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1