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

Model Number 02-02-0501

Device Problems Inadequacy of Device Shape and/or Size (1583); Device-Device Incompatibility (2919)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 03/09/2018

Event Type  malfunction  

Event Description

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 matched.In addition, the etching on the instruments 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.

Event Description

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 matched.In addition, the etching on the instruments 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.

Manufacturer Narrative

For type of device: clamp, circumcision.

Event Description

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 matched.In addition, the etching on the instruments 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.

Event Description

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 matched.In addition, the etching on the instruments 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
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave.; saint louis MO 63110
• MDR Report Key: 7398713
• MDR Text Key: 104445016
• Report Number: 7398713
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02-02-0501
• Device Catalogue Number: 02-02-0501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2018
• 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
• Treatment: NO OTHER THERAPIES; NO.
• Patient Outcome(s): Other
• Patient Weight: 3