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 Fracture (1260); Difficult to Open or Close (2921); Component Misassembled (4004)

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

Event Date 04/12/2023

Event Type  Injury  

Event Description

A patient of undisclosed gender and age underwent a colonoscopy procedure in which the physician used a cook captura pro biopsy forceps with spike.It was reported that the forceps were advanced through a fujinon scope and when attempted to open the jaws of the forceps one of the jaws broke off inside the patient.The device was removed and the jaw piece retrieved with a pair of forceps.The procedure was completed using another of the same device.Clarification of the event has been requested as the device was received for evaluation and no parts or components were missing or separated from the device received for evaluation.

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 undisclosed gender and age underwent a colonoscopy procedure in which the physician used a cook captura pro biopsy forceps with spike.It was reported that the forceps were advanced through a fujinon scope and when attempted to open the jaws of the forceps one of the jaws broke off inside the patient.The device was removed and the jaw piece retrieved with a pair of forceps.The procedure was completed using another of the same device.Clarification of the event has been requested as the device was received for evaluation and no parts or components were missing or separated from the device received for evaluation.Several attempts were made to clarify the event but were unsuccessful.Response received was that they "can not recall what happened.".

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a biohazard bag with 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 confirmed the report of the forcep jaw breaking.The device was returned in a 3 coil position.During a visual examination, it could be seen that one side of the forceps housing had separated from the coil catheter and the other side remained attached so there were no parts missing; therefore none could be left remaining in the patient.The forceps would not close with handle manipulation, but rather reopened slowly when the handle was released.Under magnification, the forceps housing and coil spring were examined for weld marks.The weld mark on the detached side of the housing is present, as well as the exposed coil catheter.There was a slight kink in the catheter at approximately 110.5 cm from the base of the handle.Also under magnification, it can be seen that the cups do not mesh together fully and the holes on the cups of the forceps are offset slightly, meaning the cups are misaligned from side to side.A function test was not possible, due to the condition of the device.The device was returned to the supplier for further evaluation and the following was provided, "the device was received for evaluation with all inner jaw assembly components present.One of the fork-half components was not attached to the coil cable, but showed evidence of weld marks on the outer surface, and on the inside surface.A mark consistent with the weld location on the fork was observed on the coiled cable, but barely visible.The other fork-half was attached to the coil cable, with a weld spot clearly visible.A kink in the cable was observed approximately 110.5 cm from the handle.The device was evaluated in the u-bend position for functionality.While holding the base of the fork to stabilize the detached component, the device was able to be actuated by manipulating the handle.The needle tail was observed to be outside of both link wires, not situated properly between them.The needle tail placement on the outside of the link wires would prevent the fork-half from having full contact with the coil cable during the laser welding process.In order for the laser welder to properly join the fork components, the needle must be properly situated within the link wires.The device was inconsistent with the original report that a jaw had broken free from the device and had to be retrieved, as there were no components missing from the inner jaw assembly.Supplier evaluation was consistent with cook's observations in that one of the fork components had become detached from the cable, but was still attached to the jaw assembly at the pivot pin.The cause of the improper needle placement was determined to be operator error.The device history record was reviewed and was manufactured (b)(6) 2022.A relevant defect was noted in the manufacturing/fqc checklist.The device history record for the lot # said to be involved was reviewed.The same manufacturing non conformances identified during the device evaluation was identified during the device history record review.Based on the review it is possible nonconforming product was released into distribution.A field action assessment was completed to determine if field action is required.In addition production was notified in an effort to heighten their awareness.Investigation conclusion: the supplier provided the following, "root cause was assigned to human error, improper needle placement prevented the fork-half from having full contact with the coil cable during the laser welding process.Operators will be advised of the complaint and retrained.A review of the device record revealed 3 relevant defects related to the non-conformance.A visual evaluation of the device found one of the fork-half components was not attached to the coil cable, however all components were present.Upon further investigation it was discovered the needle tail placement prevented the fork-half from having full contact during the laser welding process.Human error was the assignable cause.Prior to distribution, all captura pro¿ biopsy forceps with spike are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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: 16896921
• MDR Text Key: 314846178
• Report Number: 1037905-2023-00210
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 06/02/2023
• 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: FUJINON ENDOSCOPE, UNKNOWN MODEL
• Patient Outcome(s): Required Intervention