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

Model Number 02-00-0500

Device Problem Device Slipped (1584)

Patient Problem Blood Loss (2597)

Event Date 08/10/2015

Event Type  malfunction  

Manufacturer Narrative

Date code stamped into the base plate 599, indicating it was manufactured in may, 1999.Therefore, it is 16 years old.The clamp involved was returned and evaluated.The threads on the screw coming up from the base plate are knicked and damaged, which prevents the tightening nut from freely screwing down against the clamp armand properly tightening.This damage was most likely caused by parts banging together during sterilization and handling during 16 years of service.The circumcision clamp instruction manual states the following: 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 initiating the surgical procedure, you must insure the expected clamping function has been properly achieved.Important: some bleeding may occur and/or some sutures may be required depending on the prescribed surgical technique.Picture of clamp on page 3 of the instruction manual shows proper assembled clamp.

Event Description

It was reported that while assisting a physician with a circumcision clamp, it did not tighten like it should.The circumcision clamp had to be undone prior to use when the provider tighten per the procedure.It malfunctioned and did not tighten.Therefore, the infant bled more than normal and surgery had to be applied.

• Brand Name: GOMCO CIRCUMCISION CLAMP
• Type of Device: CIRCUMCISION CLAMO
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave.; st. louis MO 63110
• Manufacturer Contact: wayne karcher ; 1720 sublette ave.; st. louis, MO 63110 ; 3147712400
• MDR Report Key: 5225991
• MDR Text Key: 31499608
• Report Number: 1924066-2015-00003
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02-00-0500
• Device Catalogue Number: 02-00-0500
• Device Lot Number: 5/99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2015
• Initial Date FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 DA
• Patient Weight: 3