MAUDE Adverse Event Report: UNKNOWN GOMCO; CLAMP, CIRCUMCISION

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 05/30/2019

Event Type  malfunction  

Event Description

Baby boy was circumcised and the first gomco that was used, broke on the threads and wouldn't tighten appropriately and would not stop the bleeding.A second gomco was used successfully.

• Brand Name: GOMCO
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9246520
• MDR Text Key: 164134526
• Report Number: 9246520
• 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: 10/28/2019,10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA