MAUDE Adverse Event Report: FINE SURGICAL INSTRUMENTS, INC. GOMCO; CIRCUMCISION CLAMP 1.1 CM

Catalog Number 28-854

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2018

Event Type  malfunction  

Event Description

Physician performed circumcision.During the procedure, the top piece of the bell that rests on the gomco broke off.Physician finished the procedure without difficulty; no harm to patient or abnormal bleeding.After procedure, routine care was given and patient taken to mother.Pt discharged w/o complications related to circumcision.

• Brand Name: GOMCO
• Type of Device: CIRCUMCISION CLAMP 1.1 CM
• Manufacturer (Section D): FINE SURGICAL INSTRUMENTS, INC. ; hempstead NY 11550
• MDR Report Key: 7910357
• MDR Text Key: 121917760
• Report Number: MW5080117
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-854
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Weight: 3