MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number G47693

Device Problems Break (1069); Fracture (1260); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

Event Description

A patient of unspecified gender and age underwent an unspecified procedure in which the physician used a cook captura pro biopsy forceps with spike.It was reported that the nurse heard a 'clicking' sound when opening and closing the forceps.The nurse stated that device has dual cords [wires] and one of them broke.Another of the same device was used to complete the procedure.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.

Manufacturer Narrative

Investigation evaluation: the products said to be involved were returned in a clear plastic bag that had two open pouches from the lot number provided in the report.The labels match the products returned.Devices #1 and #2: our laboratory evaluation of the products said to be involved confirmed the report.The devices were returned in the coiled position.During visual examination, it can be seen the forks of the forcep tip (i.E.Housing) has detached from the coil cable due to the laser weld failing.As a result of this failure, the link wire is bent on one side of the cups, and it can be seen that the cups do not mesh together fully and the holes on the cups of the forceps are offset slightly (i.E.Misaligned).The forceps opens and closes during handle manipulation.The device was not function tested in the scope due to the condition of the returned device.The rest of the distal end components had no anomalies or damage.The devices were returned to the supplier for further evaluation and the following was provided, "upon visual evaluation of the devices (#1 and #2), it was observed that the jaw assembly of each device has one fork-half that has detached from the coil cable.The opposing fork-half of the jaw assembly on each device is bent inward, but remain attached to the coil cable.The needle on device #2 is bent at the tail, following the contour of the bent fork-half.Weld spots are present on both fork halves of each device.No visible damage to the catheter or handle components of either device was observed.Both devices were tested for functionality in a u-bend and 3-loop configuration.The jaws of both devices opened and closed when actuated with the handles.Audible clicking was observed when actuating both devices, but the cause was indeterminable due to the damage of the jaws.The devices were not evaluated in a scope due to the level of damage.All captura pro devices are 100% fqc inspected visually to verify adequate welds and fork alignment, as well as manually tug tested to verify proper attachment of fork to cable.It is unknown how damage occurred to the devices.".The device history records were reviewed and manufactured in july 2022.There were relevant defects noted in the fqc checklist records for handle friction.The device history record does contain a nonconformance that could potentially be related to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.Investigation conclusion: the supplier provided the following, "root cause could not be determined.Our laboratory evaluation of the product said to be involved confirmed the report based on the visual i functional examination.All captura pro devices are 100% inspected prior to shipment.The fqc checklist requires visual verification for adequate welds and fork alignment, a manual tug test to verify proper attachment of fork to cable, and verification forceps operate freely with no hesitation, smoothly with no grinding, friction or clicking while coiled.".Prior to distribution, all captura pro 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 remote.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 PRO¿ BIOPSY FORCEPS WITH SPIKE
• Type of Device: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 15490885
• MDR Text Key: 306285852
• Report Number: 1037905-2022-00532
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002476936
• UDI-Public: (01)00827002476936(17)250706(10)W4614029
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G47693
• Device Catalogue Number: BF-2.2S-230SP-40
• Device Lot Number: W4614029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2022
• 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-FUJINON - UNKNOWN MODEL