MAUDE Adverse Event Report: GOMCO CIRCUMCISION CLAMP; CLAMP, CIRCUMCISION

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

During a circumcision procedure, the performing physician detected a small metal fragment on the baby's lower abdomen.Upon closer assessment of the fragment and the gomco circumcision device utilized for the procedure, it appeared that a part of the gomco device's arm broke off during the procedure.There was no injury to the baby, though, it was noted that the baby had minimal bleeding at the circumcision site later on after the procedure was completed.Welcy allyn (baxter / hilltom), skaneateles falls, ny us.

• Brand Name: GOMCO CIRCUMCISION CLAMP
• Type of Device: CLAMP, CIRCUMCISION
• MDR Report Key: 17878368
• MDR Text Key: 325101339
• Report Number: MW5146634
• Device Sequence Number: 1
• Product Code: HFX
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Male
• Patient Weight: 4 KG