MAUDE Adverse Event Report: COOK MEDICAL LLC COOK; BIOPSY FORCEPS

Catalog Number DBF-2.4-230-20-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Date 02/06/2018

Event Type  malfunction  

Event Description

Tissue in the colon was torn as a result of using the cook biopsy forceps (ref #dbf-2.4-230-20-s).Surgeon stated that the forceps were tearing the tissue instead of taking a clean biopsy bite.Pt's bleeding was minimal and did not require further treatment.

• Brand Name: COOK
• Type of Device: BIOPSY FORCEPS
• Manufacturer (Section D): COOK MEDICAL LLC; bloomington IN 47402
• MDR Report Key: 7292633
• MDR Text Key: 100922241
• Report Number: MW5075469
• Device Sequence Number: 1
• Product Code: FCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.4-230-20-S
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 70