MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA BIOPSY FORCEPS WITHOUT SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number	DBF-2.4-230-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	07/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be 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: a corrective action has been initiated to reduce occurrences of cups opening and closing difficulties for disposable forceps.The product said to be involved is included in the scope of the corrective actions.The instructions for use state the following in regards to product inspection: "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 corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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 biopsy forceps without spike.The following was reported by the customer: "when taking a duodenal biopsy, the mechanism gave way and a clicking noise was heard.We were unable to retrieve the specimen from the forceps and had to undertake additional biopsies with a new forceps.I have not encountered this problem before.The forceps were being used correctly at the time and no undue pressure had been applied to them.".
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, the device was functionally tested.When the handle of the device was manipulated the forceps cups will open, but they will not close.Several attempts were made to close the forceps cups, but they were unsuccessful.The device was then placed down an olympus gif-q20 (2.8 mm channel) endoscope.The endoscope was put in a torturous path.When the handle was manipulated the device would open, but the cups would not close.The device was sent back to the supplier for 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 returned device was performed.The returned device was tested for "would not close".During functional testing, with the device coiled in three (3), approximately eight (8) inch loops, it was confirmed that the device would not operate properly when the handle was manipulated.The device opens but does not close.Upon further investigation and disassembly of the device tip, it was noted that the device has a broken solder joint.The reported defect was confirmed.Failure was due to a broken solder joint.The device history records for the packaging work order were reviewed.The packaging work order consisted of two (2) assembly orders, one (1), manufactured march 2017, one (1), manufactured in february 2017.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 supplier provided the following: the "forceps would not close" issue experienced by the customer was confirmed and the root cause was determined to be a broken solder joint.The supplier is currently working on improvements to create a more robust soldering process to prevent solder joints from breaking.In addition, a corrective action has been initiated to reduce occurrences of cups open/close difficulties for disposable forceps.The product said to be involved is included in the scope of the corrective actions.The instructions for use state the following in regards to product inspection: "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 forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps without 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 corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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 biopsy forceps without spike.The following was reported by the customer: "when taking a duodenal biopsy, the mechanism gave way and a clicking noise was heard.We were unable to retrieve the specimen from the forceps and had to undertake additional biopsies with a new forceps.I have not encountered this problem before.The forceps were being used correctly at the time and no undue pressure had been applied to them.".

• Brand Name: CAPTURA BIOPSY FORCEPS WITHOUT 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: 6795444
• Report Number: 1037905-2017-00536
• Device Sequence Number: 16393720
• Product Code: FCL
• UDI-Device Identifier: 00827002315761
• UDI-Public: (01)00827002315761(17)200323(10)W3843755
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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-2.4-230-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/21/2017
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1