MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. GOMCO CIRCUMCISION CLAMP

Model Number 02-02-0501

Device Problem Packaging Problem (3007)

Patient Problem Injury (2348)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: GOMCO CIRCUMCISION CLAMP
• Type of Device: CIRCUMCISION CLAMP
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave; st. louis MO 63110
• Manufacturer Contact: jon stillman ; 1720 sublette ave.; st. louis, MO 63110 ; 3142681616
• MDR Report Key: 7507041
• MDR Text Key: 108005946
• Report Number: 1924066-2018-00002
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02-02-0501
• Device Catalogue Number: 02-02-0501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA
• Patient Weight: 3