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

Model Number 02-01-0500

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2013

Event Type  malfunction  

Event Description

It was reported that the hospital did a circumcision procedure on (b)(6), but had put a 1.1 bell with a 1.3 plate together on the clamp.The clamp came apart during the procedure due to the mismatched parts.The pt had to have stitches.He did not require any further care, and was released by the original projected discharge time.The hospital indicated the parts were apparently mismatched after sterilization at the hospital.

Manufacturer Narrative

The hospital told us they mismatched the parts.The bell and the base both have the size metal stamped into them.Important: some bleeding may occur and/or some sutures may be required depending on the prescribed surgical technique.On page 5 and 6 of the operating instruction, it gives the user a chart which the facility can use to verify the size of the bell.This malfunction appears to be the result of an assembly error at the hospital.Clamp has not been returned for eval.

• Brand Name: GOMCO CIRCUMCISION CLAMP
• Type of Device: CIRCUMCISION CLAMP
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS INC.; st. louis MO 63110
• Manufacturer Contact: 1720 sublette ave.; st. louis, MO 63110 ; 3142681661
• MDR Report Key: 3750349
• MDR Text Key: 4482720
• Report Number: 1924066-2014-00001
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2014

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: 02-01-0500
• Device Catalogue Number: 02-01-0500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2014
• Initial Date FDA Received: 01/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention