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

Model Number	G31576
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
Event or Problem Description
In preparation for an esophageal biopsy procedure, the user selected a cook captura biopsy forceps without spike.It was reported that when the user opened the package, they found the tip of the forceps cup was crooked/bent.This occurred prior to patient contact; there was no impact to the patient.In addition, the patient sustained no clinical consequence and there were no adverse effects to the patient.
Additional Manufacturer Narrative
This mdr follow up report is being submitted to cancel the initial report submitted relating to this event.The evaluation determined that the forcep head was bent and misaligned, not broken; which has not historically caused or contributed to a serious injury or death.Based on further quality and medical evaluation this incident no longer meets the reporting criteria of an fda mdr report.
Event or Problem Description
This supplemental emdr is being sent to cancel the initial emdr.See h11 for further justification.

• Brand Name: CAPTURA BIOPSY FORCEPS WITHOUT SPIKE
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON POWERED, EXEMPT
• Manufacturer (Section D): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC (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: 21717696
• Report Number: 1037905-2025-00243
• Device Sequence Number: 14581515
• Product Code: PTS
• UDI-Device Identifier: 00827002315761
• UDI-Public: (01)00827002315761(17)270626(10)W4849241
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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 Model Number: G31576
• Device Catalogue Number: DBF-2.4-230-S
• Device Lot Number: W4849241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 65 KG