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-2.2S-230SP-20

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 10/20/2023

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

During an esophagogastroduodenoscopy (egd), the physician used a cook captura pro biopsy forceps with spike.It was reported that the physician had taken a biopsy.After taking the specimen out of the forceps, they noticed one of the cups had come off.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 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.The photos attached show the labeling of the device which matches the report and the distal end of the forceps with one cup missing.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with no damage to the sheath or handle.One forceps cups was missing and not included in the return.During handle actuation, the forceps cup that was present would open and close as expected.During an exam under visual magnification, it can be seen that one forceps cup, as well as its pivot pin, is missing.Additionally, the link wire for the missing forceps cup is broken.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, "visual evaluation of the returned device revealed no aesthetic defects.No damage was visible to the jaw assembly, coil cable, coating or handle components of the device.The tip assembly had missing pivot pin and one cup.The functional evaluation cannot be completed since tip parts (pivot pin, one cup) missing.The device components were disassembled and removed from the device.Device components showed no internal signs of damage.The process travelers and inspection records for the tip assemblies were reviewed and no defects were found for either of the lots, the lots were pressed using the manual.The wire connected to the missing cup was examined on the optical comparator.The wire fails to meet specification in multiple zones.The cause of the failure of the wire to meet specifications in these zones could not be determined, nor could it be determined if the damage was caused pre or post production.Captura pro devices are 100% inspected at final quality checklist.Hence, root cause for this defect is unknown." the device history records for were reviewed and was manufactured august 2023 and july 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: the supplier provided the following, "root cause could not be determined no corrective action has been assigned.The customer's complaint was confirmed.The device history record was reviewed and no anomalies were found.The visual examination of the device revealed the tip assembly was missing the pivot pin and one cup.A functional evaluation could not be performed due to the condition of the returned device.Further evaluation of the device found the wire connected to the missing cup did not meet specifications.The cause of this failure could not be determined.All devices receive a 100% inspection prior to release and shipment to ensure the device is working properly." prior to distribution, all captura pro¿ biopsy forceps with spike are subjected to a visual inspection and functional testing to ensure device integrity.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: 18142077
• MDR Text Key: 328189419
• Report Number: 1037905-2023-00571
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002476929
• UDI-Public: (01)00827002476929(17)260816(10)W4756332
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BF-2.2S-230SP-20
• Device Lot Number: W4756332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2023
• 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: FUJI ENDOSCOPE, UNK MODEL.