MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA MINI BIOPSY FORCEPS W/O SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number	DBF-1.8-160-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	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During our evaluation of the device, the cups would open but would not close when using the handle.No other anomalies were detected with the device.The device will be sent back 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 device opens but does not close.Upon disassembling the device, a butt joint was discovered with a broken control wire / link wire solder joint.No handle anomalies were discovered.The device history records were reviewed.There were two work orders and they were manufactured on 11/13/16.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 customer experienced issue of "the forcep handle broke" was confirmed; the device would open but not close.The root cause is a butt joint with a broken control wire / link wire solder joint.The approved supplier is currently working on improvements to create a more robust soldering process to prevent solder joints from breaking.These improvements are currently awaiting customer approval prior to implementation.The instructions for use state the following in regards to product inspection: "beginning at 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.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 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 an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook captura mini biopsy forceps w/o spike.At the end of the procedure, the forceps were used to take some ampullary biopsies and operated it in a normal fashion.They used it two times taking two bites each time and then the forceps handle broke on the third pass.They had gotten enough samples so they finished the procedure.On 03/31/2017, an evaluation response letter was received from the approved supplier.The supplier evaluation found that the link wire to drive wire solder joint was broken.

• Brand Name: CAPTURA MINI BIOPSY FORCEPS W/O 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: 6520383
• Report Number: 1037905-2017-00211
• Device Sequence Number: 13628294
• Product Code: FCL
• UDI-Device Identifier: 00827002530065
• UDI-Public: (01)00827002530065(17)181123(10)W3653028
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/25/2017

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-1.8-160-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2017
• Device Age: 14 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS ERCP ENDOSCOPE