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

Catalog Number	DBF-2.8SJN-230-40-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	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A functional test was performed on the returned forceps device.When the handle was manipulated, the device would open, but would not close.The device will be sent back to the supplier for further evaluation.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 product was returned to the approved supplier for evaluation and the investigation is on-going.Once additional information has been received a follow-up emdr report will be provided.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A functional test was performed on the returned forceps device.When the handle was manipulated, the device would open, but would not close.The device will be sent back to the supplier for further evaluation.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 product was returned to the approved supplier for evaluation and the investigation is on-going.Once additional information has been received a follow-up emdr report will be provided.
Event or Problem Description
In preparation for a procedure, the user selected a cook captura serrated jumbo forcep- no spike.The device was taken out of the package.During table testing [prior to the procedure], the user went to open and close the forceps, and the handle broke.Another device was used for the procedure.When the device was received for evaluation, the cups of the forceps would open but they would not close.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.A functional test was performed on the returned forceps device.When the handle was manipulated, the device would open, but would not close.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 "handle broke." during functional testing, it was confirmed that the device would not operate properly when the handle was manipulated.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 was confirmed.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 "handle broken" was confirmed; the device has a 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 currently working on improvements for a more robust soldering process to prevent solder joints from breaking.The 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.

• Brand Name: CAPTURA SERRATED JUMBO 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: 6547252
• Report Number: 1037905-2017-00254
• Device Sequence Number: 1170360
• Product Code: FCL
• UDI-Device Identifier: 00827002567221
• UDI-Public: (01)00827002567221(17)191215(10)W3808123
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/07/2017

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-2.8SJN-230-40-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/12/2017
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1