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	02/09/2017
Type of Reportable Event	Malfunction
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.The device was returned with a yellow/brown substance in the cups.The cups opened slowly but would not close when handle was manipulated.The cups were cleaned off in the cidex solution and then the cups opened normally but would not close when using the handle.There were no other anomalies detected with the device.The forceps were sent back to the supplier for further evaluation.The supplier provided the following information: 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 other anomalies were discovered.The device history records for packaging work order was reviewed.The pwo consisted of two assembly orders (aos).The date of manufacture for the assembly orders (aos) was 10/05/16.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 "device would not close" 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 supplier is currently working on improvements to create a more robust soldering process to prevent solder joints from breaking.The instructions for use state: "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 forceps with 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.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 upper endoscopic procedure, the physician used a cook captura serrated forceps with spike.The device would not close and had to be removed with the endoscope.

• 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: 6525656
• Report Number: 1037905-2017-00229
• Device Sequence Number: 11063092
• Product Code: FCL
• UDI-Device Identifier: 00827002530065
• UDI-Public: (01)00827002530065(17)191019(10)W3785929
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 04/27/2017

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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2017
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/27/2017
• 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: PENTAX ENDOSCOPE (UNKNOWN MODEL)