MAUDE Adverse Event Report: FORCEPS; FORCEPS, SURGICAL, GYNECOLOGICAL

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2022

Event Type  Injury  

Event Description

During hysterectomy, forceps snapped while in use in patient's abdomen.Fda safety report id # (b)(4).

• Brand Name: FORCEPS
• Type of Device: FORCEPS, SURGICAL, GYNECOLOGICAL
• MDR Report Key: 13603673
• MDR Text Key: 286431199
• Report Number: MW5107733
• Device Sequence Number: 1
• Product Code: HCZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female