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

Catalog Number DBF-1.8-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2018

Event Type  malfunction  

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.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use includes the following to ensure proper use of the device: "endoscope should remain as straight as possible when inserting and withdrawing forceps.Forceps cups must remain closed during introduction into, advancement through, and removal from endoscope.If cups are open, damage to forceps and endoscope may occur.Gentle pressure must be used when operating forceps handle.Excessive pressure will result in rigidity of forceps, which may damage forceps and/or endoscope." the instructions for use under product inspection states: "beginning at handle and moving toward cups, uncoil forceps making sure not to stretch cable.Open and close cups, to verify smooth handle operation and appropriate cup action.Exercising handle while forceps is coiled may damage forceps performance characteristics." prior to distribution, all captura bronch biopsy forceps no spike are subjected to a visual inspection and functional test to ensure proper workability.Corrective action: 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 Description

During an endoscopic procedure, the physician used a cook captura bronch biopsy forceps no spike.The user had a hard time opening and closing the forceps.A new forceps was opened and used to complete the procedure.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number w3837646.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 placed down an olympus bf-160 endoscope that had a 2.0mm biopsy accessory channel.The endoscope was retroflexed to show a worst case scenario.The cups will open, but they will 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 was returned in a zip type bag with proof of decontamination.The returned device was tested for "would not close." during functional testing, with the device coiled in one (1), eight inch loop, it was confirmed that the device would not operate properly when the handle was manipulated.The device would open but would not close as intended.Upon further investigation and disassembly of the device tip, it was noted that the device solder connection was broken.The reported defect of "would not close" was confirmed.Root cause of failure was due to a broken solder connection.The device history records were reviewed and were manufactured january 2017.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 reported issue of "would not close" was confirmed.A broken solder connection was determined to be the cause of the defect.The operators involved with the soldering process for this lot will be advised of the issue.The instructions for use state the following under product inspection: "beginning at handle and moving toward cups, uncoil forceps making sure not to stretch cable.Open and close cups, to verify smooth handle operation and appropriate cup action.Note: exercising handle while forceps is coiled may damage forceps performance characteristics." prior to distribution, all captura bronch biopsy forceps no spike are subjected to a visual inspection and functional test to ensure proper workability.Corrective action: 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 Description

"during an endoscopic procedure, the physician used a cook captura bronch biopsy forceps no spike.The user had a hard time opening and closing the forceps.A new forceps was opened and used to complete the procedure." the following handwritten note was received with the device for evaluation on (b)(6) 2018: "the biopsy forceps [were] unable to close after third pass.[they] worked fine for biopsies, then while opening after the third biopsy to place [the samples] in formulin, [the user] heard a click and forceps were stuck in the open position.".

• Brand Name: CAPTURA BRONCH BIOPSY FORCEPS NO SPIKE
• Type of Device: FCL, FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7266668
• MDR Text Key: 100128902
• Report Number: 1037905-2018-00053
• Device Sequence Number: 1
• Product Code: FCL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-1.8-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2018
• Device Age: 10 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/12/2018
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE, UNKNOWN MODEL