MAUDE Adverse Event Report: OWENS & MINOR GOMCO; CLAMP, CIRCUMCISION

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/12/2018

Event Type  malfunction  

Event Description

The obstetrician was performing the infant's circumcision using a gomco device.The time-out had occurred and the local anesthesia had been placed.After waiting the required 5 minutes, the physician began the procedure.She placed the 1.3 size gomco clamp on the penis and tightened the knob in place.After waiting another 5 minutes, the physician began to use the scalpel to cut the foreskin around the gomco.She was approximately halfway around the circumference of the penis when the device fell off.The device was readjusted and the incision was completed.There was bleeding around the site and silver nitrate was used for hemostasis.There appeared to be a defect in the skin over the shaft of the penis, so the physician consulted urology for consult and repair.The urologist came in and repaired the laceration with 2 sutures, and then applied numerous sutures circumferentially to reapproximate the penile and preputial skin.The provider attempted to use the gomco device correctly, but investigation of the incident and the device has concluded that we were unable to determine that the device failed.That being said, we were curious as to why the screw knob on the device can be screwed on both right side up and upside down.This seemed like a risk to us.

• Brand Name: GOMCO
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): OWENS & MINOR; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 7591181
• MDR Text Key: 110752227
• Report Number: 7591181
• 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: User Facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/30/2018

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: Physician
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other