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	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The forceps were returned with the cups open and no visual damage to the sheath.The cups were opened with one of the jaws bent to one side, and it appeared to have a link wire bent or broken.When the handle was manipulated the cups would not move and a grinding/dragging feeling was felt inside of the handle.The device was 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.Evaluation of the device determined that the returned device was tested for "open/close".During functional testing, with the device coiled in two (2), approximately eight (8) inch loops, it was confirmed that the device would not operate properly when the handle was manipulated.The device would not open or close.Upon further investigation of the device tip, it was noted that the device has a bent link wire which has caused one of the cups to lock in the open position.Also the link wires are broken at the distal side of the solder joint.During the evaluation the condition of the link wire appeared as if someone had jammed something into it forcing it to bend and break.The reported defect was confirmed.Root cause for the bent link wire and broken link wires cannot be determined.The device history records for the packaging work order were reviewed.The packaging work order consisted of two (2) assembly orders and were manufactured in october 2016.No relevant defects were noted in the manufacturing and/or final quality control checklist 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 "forceps will not open or close" issue experienced by the customer was confirmed.During functional testing, the device would not operate properly.It was determined that the device has a bent link wire which resulted in one of the cups to lock into the open position.The root cause of the bent link wire could not be determined.Each device received a 100% inspection prior to shipment to include functionality of the cups for open/close.If the link wire was bent prior to shipment, the device would not have passed the final quality control inspection.Prior to distribution, all cook captura mini biopsy forceps w/o 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 a biopsy procedure, the physician used a cook captura mini biopsy forceps w/o spike.The user confirmed that the cups could open and close during a functional test after opening the package.The user then inserted the forceps into the endoscope accessory channel and attempted to open the cups at the target site, but the cups would not open.Another device was used instead to complete the procedure.There have been no adverse effects to the patient reported.The device was evaluated on 08/30/2017.This device was returned with the cups open and they will not close.The cups are bent and appear to have a link wire bent and 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: 6885837
• Report Number: 1037905-2017-00603
• Device Sequence Number: 16258626
• Product Code: FCL
• UDI-Device Identifier: 00827002530065
• UDI-Public: (01)00827002530065(17)191130(10)W3800011
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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: 08/21/2017
• Device Age: 9 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1