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

Catalog Number BF-2.8SJ-230SP-40

Device Problems Difficult to Open or Close (2921); Component Misassembled (4004)

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

Event Date 08/08/2023

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 confirmed the report.The device was returned in a 3 coil position.During a visual examination, it was noted that the cups were partially open.During a function test, it was noted that the cups would initially open fully but would not close when the handle was manipulated.Upon further manipulation of the handle, the cups would not open or close at all when the handle was actuated.A function test in the endoscope was not possible, due to the condition of the device.No other anomalies were detected with the device.The device was returned to the supplier for further evaluation and the following was provided, "the device was received with the handle spool bottomed out at the thumb loop of the handle stem.No damage was observed in the jaws, coil cable, coating or external surfaces of the handle components.The device could not be actuated using the handle as received.No tension could be felt in the spool, which would indicate detachment of a component internally.The device jaws could be manually closed at the tip, and then opened by pushing the spool towards the distal end of the device, but could not close the jaws when retracted, as no tension on the control wire could be felt.The device handle was disassembled for further investigation; one of the two spool components was carefully separated and removed in order to view the position of the pushrod and clip within the handle stem and other remaining spool component as installed.Upon opening of the spool, it was confirmed that the clip was not properly installed/seated within the clip slot inside the spool components during assembly.Gouge marks were observed on the internal clip slots of the handle spool components consistent with the pushrod.This confirmed that during handle assembly, the clip was improperly seated within the slots of the spool halves, and were assembled with the proximal end of the pushrod clamped between the clip slots of the spool components, causing the gouge marks.After removal of the spool components, the jaws of the device were able to be actuated by manipulating the pushrod/clip assembly within the handle stem.The jaws could be fully opened and fully closed by pushing and pulling the pushrod.The root cause of the nonconforming device was determined to be improper assembly.The device history record was reviewed and manufactured may 2023.There were no relevant defects noted in the manufacturing/fqc checklist.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: our laboratory evaluation confirmed the complaint.The supplier provided the following, "the complaint was confirmed.A review of the device record did not reveal any defects related to the non-conformance.A functional evaluation of the device found the device could not be actuated.Further investigation revealed that the clip had been improperly seated within the slots of the spool halves.Root cause was determined to be improper assembly.Operators will be advised of the complaint and retrained." prior to distribution, all captura pro biopsy forceps are subjected to a visual inspection and functional test 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.

Event Description

During an esophagogastroduodenoscopy, the physician used a cook captura pro biopsy forceps with spike.It was reported [that] once down the scope and out the distal end, they said it was difficult to open and close the jaws appropriately.One of the jaws was not moving properly.So, they removed it and successfully completed the procedure with another device of the same type (same lot too).There was no reportable information at this time.The device was evaluated on (b)(6) 2023.During the evaluation it was noted that during a functional test, the cups would open fully but would not close when the handle was manipulated.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 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: 17797898
• MDR Text Key: 324019242
• Report Number: 1037905-2023-00454
• Device Sequence Number: 1
• Product Code: PTS
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BF-2.8SJ-230SP-40
• Device Lot Number: W4731201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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: OLYMPUS GIF-19H ENDOSCOPE