MAUDE Adverse Event Report: GOMCO 1.1; CLAMP, CIRCUMCISION

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Laceration(s) (1946)

Event Date 11/24/2021

Event Type  Injury  

Event Description

Clamp fell off during the incision of the vertical shaft of the penis during a standard gomco circumcision performed on newborn.Urology repair was required.Welch allyn.Fda safety report id# (b)(4).

• Brand Name: GOMCO 1.1
• Type of Device: CLAMP, CIRCUMCISION
• MDR Report Key: 12954701
• MDR Text Key: 282004990
• Report Number: MW5105884
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention