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

Catalog Number DBF-2.8SJ-230-S

Device Problems Failure to Align (2522); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2017

Event Type  malfunction  

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.An additional twenty-three (23) sealed devices from the lot number provided in the report was returned.Device 1: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.A functional test was performed on the device by testing to see if the cups will open or close.When the handle of the device was manipulated the forceps cups will open and close as intended.On multiple attempts the forceps cups would open and close as intended.The device was then placed down a pentax ec-3830tl (3.8 mm channel) endoscope.The endoscope was placed in a curved position to simulate worst-case scenario.The handle of the device was manipulated and the cups will open and close as intended.Device 2: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.A functional test was performed on the device by testing to see if the cups will open or close.When the handle of the device was manipulated the forceps cups will open and close as intended.On multiple attempts the forceps cups would open and close as intended.The device was then placed down a pentax ec-3830tl (3.2 mm channel) endoscope.The endoscope was placed in a curved position to simulate worst-case scenario.The handle of the device was manipulated and the cups will open and close as intended.The forceps cups were examined under magnification.During our evaluation the cups were visually evaluated and potential cup misalignment was observed.The device is being sent back to the supplier for further evaluation where the final determination of cup misalignment will be determined based on the manufacturer¿s specifications.Both devices along with the additional sealed devices were sent back to the supplier for further evaluation.Investigation conclusion: the product was returned to the approved supplier for evaluation and the investigation is on-going.Once additional information has been received a follow-up emdr report will be provided.

Event Description

The following was reported on (b)(6) 2017: during an endoscopic biopsy procedure, the physician used two (2) captura serrated jumbo forceps no spike.The customer complained that the forceps head is deviated.The products cannot be used.The following was received via the complaint form on 07/09/2017: after opening, the branches [forceps cups] would not close anymore.The devices were evaluated on 07/24/2017.One (1) of the devices was found to be potentially misaligned.

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.An additional twenty-three (23) sealed devices from the lot number provided in the report was returned.Device 1: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.A functional test was performed on the device by testing to see if the cups will open or close.When the handle of the device was manipulated the forceps cups will open and close as intended.On multiple attempts the forceps cups would open and close as intended.The device was then placed down a pentax ec-3830tl (3.8 mm channel) endoscope.The endoscope was placed in a curved position to simulate worst-case scenario.The handle of the device was manipulated and the cups will open and close as intended.Device 2: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.A functional test was performed on the device by testing to see if the cups will open or close.When the handle of the device was manipulated the forceps cups will open and close as intended.On multiple attempts the forceps cups would open and close as intended.The device was then placed down a pentax ec-3830tl (3.2 mm channel) endoscope.The endoscope was placed in a curved position to simulate worst-case scenario.The handle of the device was manipulated and the cups will open and close as intended.The forceps cups were examined under magnification.During our evaluation the cups were visually evaluated and potential cup misalignment was observed.The device is being sent back to the supplier for further evaluation where the final determination of cup misalignment will be determined based on the manufacturer¿s specifications.Both devices along with the additional sealed devices were sent back to the supplier for further evaluation.The supplier provided the following evaluation: a total of twenty-five (25) devices from the reported event were returned.Two used (2) devices were in a zip type bag with proof of decontamination, and twenty-three (23) additional devices in sealed pouches (unused).Evaluation of the devices was performed.Device 1: for the returned device, the device was tested for "would not close".During functional testing, with the device coiled in three (3), eight (8) inch loops, it was not confirmed that the device would not operate properly when the handle was manipulated.The device opened and closed properly.The reported defect of "would not close" was not confirmed.Device 2: for the returned device, the device was tested for "would not close".During functional testing, with the device coiled in three (3), eight (8) inch loops, it was not confirmed that the device would not operate properly when the handle was manipulated.The device opened and closed properly.The reported defect of "would not close" was not confirmed.The device was also evaluated for "potential cup misalignment".Under magnification, the visible material thickness for device 2 was measured to be greater than the maximum allowed thickness specified.Misalignment was confirmed.The device was measured in two places under magnification.The distance between fork arms for device 2 measured relatively parallel and satisfy the maximum allowable dimension.Devices 3-25 : for the returned devices, the devices were tested for "would not close".During functional testing, with the devices coiled in three (3), eight (8) inch loops, it was not confirmed that the devices would not operate properly when the handle was manipulated.The devices opened and closed properly.The reported defect of "would not close" was not confirmed.The devices were also evaluated for "potential cup misalignment".Misalignment was not detected during visual inspections.The device history records were reviewed and consisted of one assembly order (ao) manufactured may 2016.The assembly order had devices rejected during manufacturing or final quality control (fqc) for relevant defects.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 would open but would not close' issue was not confirmed for the two (2) devices that were used during a procedure.An evaluation of the additional twenty-three (23) devices sealed in pouches was performed and each device opened and closed properly.The issue experienced in the field was not confirmed.An additional evaluation of "misaligned cups" was performed.One (1) of the two (2) returned used devices was confirmed to have misaligned cups.The visible material thickness was greater than the thickness specified.The fork arms were determined to be relatively parallel and within the allowable dimension.A 100% inspection is performed on all devices prior to shipment.Therefore, it is likely that the misalignment occurred during use of the device.The additional twenty-three (23) unused devices were also evaluated for misaligned cups, but misalignment was not detected.Prior to distribution, all captura serrated jumbo forceps no 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.

• Brand Name: CAPTURA SERRATED JUMBO FORCEPS NO SPIKE
• Type of Device: FCL, FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6753576
• MDR Text Key: 81499829
• Report Number: 1037905-2017-00509
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 00827002536425
• UDI-Public: (01)00827002536425(17)190608(10)W3732053
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.8SJ-230-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/06/2017
• Device Age: 13 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1