MAUDE Adverse Event Report: FINE SURGICAL INSTRUMENT INC. GOMCO TYPE CIRCUMCISION CLAMP DISP CHROME PLATED NEWBORN; GOMCO SIZE 1.1

Catalog Number 28-854

Device Problems Defective Component (2292); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/10/2017

Event Type  malfunction  

Event Description

Circumcision proc performed by physician using a 1.1 gomco circumcision clamp.The clamp was applied; the screw threaded without difficulty.Generally the gomco needs to be unscrewed to release the clamp, but this time the gomco and clamp came off without being unscrewed.Silver nitrate stick was used to control bleeding.After the event and upon inspection, there was a small defect noted on the thread of the post on the gomco.

• Brand Name: GOMCO TYPE CIRCUMCISION CLAMP DISP CHROME PLATED NEWBORN
• Type of Device: GOMCO SIZE 1.1
• Manufacturer (Section D): FINE SURGICAL INSTRUMENT INC.; hempstead NY
• MDR Report Key: 7138657
• MDR Text Key: 95720933
• Report Number: MW5074163
• Device Sequence Number: 1
• Product Code: HXD
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: 1 DA
• Patient Weight: 3