MAUDE Adverse Event Report: KOCHER FORCEPS

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

During a knee operation with an aquamantys 2.3 device, the cut of the patient's the intra-articular hemangioma of knee was conducted.The kocher forceps were hanging after holding the joint capsule for opening the surgical field.A burn was found, with a form like kocher forceps was found on the patient's knee.It is unknown how the burn was treated or what other events led to the burn.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FORCEPS
• Type of Device: FORCEPS
• Manufacturer (Section D): KOCHER
• MDR Report Key: 17531485
• MDR Text Key: 321133319
• Report Number: MW5138400
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1