MAUDE Adverse Event Report: GOMCO DEVICE FOR CIRCUMCISION 1.1 CLAMP; CLAMP, CIRCUMCISION

Device Problem Sharp Edges (4013)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/25/2018

Event Type  malfunction  

Event Description

Physician was doing a circumcision using the gomco device with a 1.1 clamp.As the procedure was completed they noted bleeding from the side of the baby's penis.Pressure was applied, followed by silver nitrate and eventually stitches were required to stop the bleeding.Upon close inspection of the gomco device, it was noted that the "bell" had a sharp edge.We don't have a method to track how old the device might have been or how many times it has been used and reprocessed.As a result, two gomco devices with 1.1 clamps were taken out of service to avoid this from happening again.

• Brand Name: GOMCO DEVICE FOR CIRCUMCISION 1.1 CLAMP
• Type of Device: CLAMP, CIRCUMCISION
• MDR Report Key: 7981789
• MDR Text Key: 124555379
• Report Number: 7981789
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 DA