MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for GOMCO manufactured by Owens & Minor.
[110752226]
Patient Sequence No: 1, Text Type: N, H10
[110752227]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7591181 |
| MDR Report Key | 7591181 |
| Date Received | 2018-06-12 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-05-12 |
| Report Date | 2018-05-30 |
| Date Reported to FDA | 2018-05-30 |
| Date Reported to Mfgr | 2018-05-30 |
| Date Added to Maude | 2018-06-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOMCO |
| Generic Name | CLAMP, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2018-06-12 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR |
| Manufacturer Address | 9120 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-12 |