MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number G47698

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved determined cup misalignment.A functional evaluation of the handle was performed and the cups open and close, however one of the link wires is bent and the cup does not open and close as intended during every handle manipulation.The cups fully open, but when in the closed position, the teeth do not mesh together on one side leaving a visible gap.The other side of the teeth come together and there is no gap visible.Also, when the cups are closed, the cups seem to tilt to one side.This is most likely due to the damage on one of the link wires.During a visual evaluation, the cups appear to be misaligned.The device was not functionally tested in the endoscope, due to the condition of the returned device.The device was sent back to the supplier for further evaluation.The supplier provided the following: "one device was returned in a zip type bag with proof of decontamination.Visual evaluation: the forceps were visually evaluated.One of the link wires was bent.Functional evaluation: the device will not consistently open and close properly.Sometimes one cup does not always close.Sometimes both cups bend to one side.The device does not function as intended.The forceps have been damaged.There was a visible bend in the link wire.The supplier was unable to determine when or how the link wire was damaged/bent.No details were provided on the use of the device.The condition of the device is consistent with an extreme force being placed directly on the wire or the cup.Root cause: unknown." the device history records were reviewed and determined to be manufactured in june 2019.The manufacturing records and/or final quality control checklist did not indicate relevant defects.Investigation conclusion: the supplier provided the following: "the user's reported issue 'forcep cups did not function' was confirmed.The customer reported that the forcep cups did not function as expected and observed that the link wire was bent, was also confirmed.The damage to the device was consistent with excessive force.A root cause was not determined.All devices receive a 100% inspection prior to release and shipment." although the supplier did not specifically state that the cups were misaligned, the link wire were bent and caused the cup to tilt outward, not lined up with the other cup.There was a visible gap on this side, where the teeth did not come together.This led the cups to be misaligned.The link wire must have become damaged due to an external force during use.The device cups were misaligned when the device was received.The damage on the link wire is hindering the device from functioning as intended.The instructions for use states: "note: keep end of forceps extending from accessory channel straight at all times.Allowing forceps to hang from accessory channel may cause damage to forceps." ".Caution: if forceps fail to close, slowly pull cups against channel opening.Remove endoscope and forceps as a unit, then manually close cups and withdraw forceps from endoscope." ".If resistance is met while withdrawing forceps, straighten endoscope tip.Do not apply excessive force when removing forceps, as damage to forceps and/or endoscope may occur." prior to distribution, all captura pro¿ biopsy forceps with spike are subjected to a visual inspection and functional testing 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 a biopsy procedure, the physician used a cook captura pro biopsy forceps without spike.When the customer put the product down the channel of the endoscope, and went to open the device, one of the cups was lying flat and broken.One of the wires appears to not be activating [actuating the cups, only one cup will actuate].The customer gently pulled device back to close the device, pulled it out of the endoscope, and used another of the same device to complete the procedure.They tested it outside the patient but it did not work outside the patient either.There was no reportable information at this time.The device was received for evaluation on 20-nov-2019 and found to be misaligned.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE
• Type of Device: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): 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: 9477358
• MDR Text Key: 220203408
• Report Number: 1037905-2019-00774
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002476981
• UDI-Public: (01)00827002476981(17)220610(10)W4224607
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/11/2019

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 Expiration Date: 06/10/2022
• Device Model Number: G47698
• Device Catalogue Number: BF-2.4SL-230-20
• Device Lot Number: W4224607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• 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
• Patient Age: 49 YR