MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-11 for GOMCO CIRCUMCISION CLAMP 02-02-0501 manufactured by Allied Healthcare Products, Inc..
[108005946]
Clamps have not been returned for evaluation. We were told the sizes were matched and the clamps were put back into service. Date code on clamps is unknown. If you try to assemble 1. 45 bell (stud) with a 1. 45 base plate, it cannot be assembled because the bell (stud) falls through the base plate. If you assemble a 1. 45 bell (stud) into a 1. 3 base plate, the arm will sit at an obvious improper angle and the bell (stud) will hang too far below the base plate for proper use. The size of the clamps is metal stamped on both the base plate and the bell (stud). Parts from different clamps should not be mixed during cleaning and sterilization. We cannot determine if the parts in question were made by gomco or from some other manufacturer from the pictures that were sent in. The instruction manual states the following: warning: this clamp must never be used if component parts are, damaged, missing, clearly worn, or the assembled device does not perform as described. Prior to use, always insure that plate and bell are the same size. Prior to initiating surgical procedure, you must insure that the expected clamping function has been properly achieved. Use only component parts manufactured by "gomco" when assembling this device. Important: some bleeding may occur and/or some sutures may be required depending on the prescribed surgical technique. A chart of bell sizes for comparing bell to size is on page 6 of the manual.
Patient Sequence No: 1, Text Type: N, H10
[108005947]
It was reported that a neonate underwent circumcision by a provider using a gomco clamp. The clamp that was retrieved from sterile packaging had a base and a bell that were different sizes. Despite being different sizes, the instrument was able to be assembled as if the pieces match. In addition, the etching on the instrument indicating the size is on the underside of the equipment, is extremely small, and is the same color as the instrument (silver metal). The neonate sustained a skin injury that required urology consult and revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1924066-2018-00002 |
| MDR Report Key | 7507041 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-04-10 |
| Date Added to Maude | 2018-05-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JON STILLMAN |
| Manufacturer Street | 1720 SUBLETTE AVE. |
| Manufacturer City | ST. LOUIS MO 63110 |
| Manufacturer Country | US |
| Manufacturer Postal | 63110 |
| Manufacturer Phone | 3142681616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOMCO CIRCUMCISION CLAMP |
| Generic Name | CIRCUMCISION CLAMP |
| Product Code | HFX |
| Date Received | 2018-05-11 |
| Model Number | 02-02-0501 |
| Catalog Number | 02-02-0501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 1720 SUBLETTE AVE ST. LOUIS MO 63110 US 63110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-11 |