MAUDE Adverse Event Report: GOMCO CIRCUMCISION CLAMP 1.3 CM ; CLAMP, CIRCUMCISION

Model Number 1214

Device Problem Unintended Movement (3026)

Patient Problem Blood Loss (2597)

Event Date 11/12/2019

Event Type  Injury  

Event Description

During circumcision, 1.3 cm gomco "click" heard and unit shifted, bleeding seen around bell base.Stopped, reassembled unit, and completed procedure.Baby had bleeding due to the brief loss of hemostasis during the procedure.No injury to penis.Fda safety report id# (b)(4).

• Brand Name: GOMCO CIRCUMCISION CLAMP 1.3 CM
• Type of Device: CLAMP, CIRCUMCISION
• MDR Report Key: 9349256
• MDR Text Key: 167378550
• Report Number: MW5091203
• 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: No Information
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1214
• Device Lot Number: 7117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 12 DA