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

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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2017

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.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described.When the device was returned it was cut at 2.1 cm from the distal end of the handle.A visual inspection under magnification was performed to verify the cut.Due to the condition of the returned device we could not perform a functional test to verify if the forceps cups could open and close as intended.No section of the device appeared to be missing during the return.The device was sent 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 could not be tested for "would not close".The device was cut approximately 2.0 cm from the distal end of the handle by the end user.Functional testing could not be completed to confirm the failure mode.However, upon further investigation and disassembly of the device tip, it was noted that the solder joint was broken.It is possible that the device would not close due to broken solder joint (butt joint) observed during the evaluation.The device history records were reviewed.The date of manufacture for this assembly order (ao) was december 2016.Relevant defects were noted in the records during manufacturing and/or fqc.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 "would not close" could not be confirmed; the device was cut by the end user could not be functionally tested to determine if the cups open and closed as intended.However, upon further investigation and disassembly of the device tip, it was noted that the solder joint was broken.It is possible that the device would not close due to broken solder joint (butt joint).The user stated that the forceps cups could not close, however they cut the device near the handle "to fidget with the wires".It is unknown at which point the solder joint broke.The instructions for use state: "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.

Event Description

During an endoscopic procedure, the physician used a cook captura serrated forceps with spike.They were attempting a biopsy when they felt the handle break and they could not close the forceps.They could not take it out of the endoscope and cut the handle off to fidget with the wires.They eventually were able to pull the whole endoscope out of the patient.

• Brand Name: CAPTURA SERRATED FORCEPS WITH 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: 6608485
• MDR Text Key: 76548241
• Report Number: 1037905-2017-00347
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 00827002561335
• UDI-Public: (01)00827002561335(17)191214(10)W3808127
• 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
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.4SN-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: 05/05/2017
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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
• Treatment: ENDOSCOPE UNKNOWN MAKE OR MODEL