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

Catalog Number	DBF-2.4SN-230SP-20-S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 functional test, the forcep handle was manipulated to verify the forceps cups would open and close as intended.During the functional test after several attempts, the forceps cups will open, but they will not close.When the forceps cups are opening, the handle feels rough.After a visual inspection of the handle, nothing appeared to be damaged.There also appeared to be a pebax tag on the distal end of the sheath.The device was sent back to the supplier for further evaluation.The supplier provided the following evaluation: one device from the reported event lot was returned in a zip type bag with proof of decontamination.The device was tested for "would not open." during functional testing, it was confirmed that the device would open but would not close when manipulated using the handle.Upon disassembly of the device tip, it was noted that the solder joint was broken.The reported defect was confirmed for the device.Under magnification, the presence of a pebax tag was confirmed.The device history records were reviewed and the date of manufacture was february 2017.There were devices rejected for relevant defects in manufacturing and/or final quality control.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 customer experienced issue of "would not close" was confirmed; the device has butt joint that has broken at the solder connection.The root cause is a butt joint with a broken control wire / link wire solder joint.The supplier is working on improvements to create a more robust soldering process to prevent solder joints from breaking.The customer experienced issue of "pebax tag" was also confirmed on one device.Awareness training will be provided to prevent recurrence.Instructions for use states: "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 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
In preparation for an endoscopic biopsy procedure, the physician selected a captura serrated forceps with spike.The forceps would not open when tested during preparation.The device did not make patient contact.They successfully completed the procedure with another forceps.On 05/04/2017, the device was received for evaluation.It was found that the jaws 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: 6593798
• Report Number: 1037905-2017-00330
• Device Sequence Number: 13655118
• Product Code: FCL
• UDI-Device Identifier: 00827002561328
• UDI-Public: (01)00827002561328(17)200215(10)W3831969
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2017

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: No Information
• Device Catalogue Number: DBF-2.4SN-230SP-20-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1