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

Catalog Number DBF-2.4SL-230SP-20-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: during the evaluation of the returned of the device, a functional test was performed to ensure the forceps cups would open and close.During the functional test, when the handle was manipulated, the forceps cups would open, but they would not close.Several attempts were made to close the forceps cups, but none of the attempts were successful.The device was sent back the supplier for further evaluation.The following was received from the supplier: one device from a correct lot was returned in a zip type bag with proof of decontamination.The device 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.The device history records were reviewed and the date of manufacture was february 2017.One device was rejected for relevant defects in manufacturing and/or final quality control.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 "got stuck in the open position" was confirmed; 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.Instructions for use states: "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 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 biopsy procedure, the physician used a captura serrated large forcep-spike.The forceps got stuck in the open position.They felt like the hand mechanism broke.The user was eventually able to close the forceps and complete the procedure with this device.There were no adverse effects to the patient.The device was received for evaluation on 05/03/2017.It was found that the cups of the forceps would not close at all.

• 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: 6593800
• MDR Text Key: 76150003
• Report Number: 1037905-2017-00329
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 00827002560871
• UDI-Public: (01)00827002560871(17)200313(10)W3839390
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.4SL-230SP-20-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: 04/24/2017
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2017
• 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