MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC CAPTURA BIOPSY FORCEPS WITHOUT SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Catalog Number	DBF-2.4-230-S
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In preparation for a colonoscopy examination, the user selected a cook captura biopsy forceps without spike.It was reported that the nurse opened the outer packaging of the disposable biopsy forceps and inspected the biopsy forceps head.When the colonoscope was used, it was discovered the forceps head was bent and the forceps flap was stuck in open position.The procedure was completed with another same device.This occurred prior to patient contact; there was no impact to the patient.
Additional Manufacturer Narrative
Continued: investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Note: exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps without 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 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.

• Brand Name: CAPTURA BIOPSY FORCEPS WITHOUT SPIKE
• Common Device Name: 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): WILSON COOK MEDICAL INC.; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 8002454707
• MDR Report Key: 19002687
• Report Number: 1037905-2024-00186
• Device Sequence Number: 18268138
• Product Code: PTS
• UDI-Device Identifier: 00827002315761
• UDI-Public: (01)00827002315761(17)260607(10)W4734655
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2026
• Device Catalogue Number: DBF-2.4-230-S
• Device Lot Number: W4734655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female