MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEP-SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number DBF-2.4SL-230SP-40-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During an evaluation of the device, a functional test was performed.When the handle was manipulated, the cups would open, but they would not close.Several attempts were made to close the forceps cups by handle manipulation, but all attempts were unsuccessful.A visual examination was performed and a kink was observed right directly below the handle of the device.This kink could have occurred when the user was trying to remove the device from the endoscope.The device will be sent back to the supplier for 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

During an esophagogastroduodenoscopy (egd), the physician used a cook cook captura serrated large forcep-spike.After placing the forceps down the endoscope to obtain biopsies of the duodenum (endoscope was not torqued), the forceps were opened and when closing on duodenal tissue the technician felt a pop.She was able to reopen the forceps but not close the cups again.The endoscope was removed from the patient with the forceps still in the accessory channel.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During an evaluation of the device, a functional test was performed.When the handle was manipulated, the cups would open, but they would not close.Several attempts were made to close the forceps cups by handle manipulation, but all attempts were unsuccessful.A visual examination was performed and a kink was observed right directly below the handle of the device.This kink could have occurred when the user was trying to remove the device from the scope.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.The returned device from the reported event was tested for "would not close".During functional testing, it was confirmed that the device would open but would not close when manipulated using the handle.Upon disassembly of the device tip, it was noted that the solder joint was broken.The reported defect was confirmed for the device.According to cook evaluation, during a visual inspection of the device, they noticed that "a kink was observed right directly below the handle of the device".This reported defect was confirmed.A significant kink was noticeable right after the handle nose cap, in the proximal end of the coiled cable.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 "able to reopen the forceps but not close" was confirmed; the device opens but does not close.The device has a butt joint that has broken at the solder connection.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.Additional inspection of the device also noted a significant kink was noticeable right after the handle nose cap, in the proximal end of the coiled cable.The root cause for the kink was undetermined.Awareness training will be provided to production and final quality control personnel regarding this defect.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 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 LARGE FORCEP-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: 6591721
• MDR Text Key: 76177872
• Report Number: 1037905-2017-00306
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 00827002560765
• UDI-Public: (01)00827002560765(17)200405(10)W3849570
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.4SL-230SP-40-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2017
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2017
• 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