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

Model Number 02-02-0501

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/02/2014

Event Type  Injury  

Event Description

It was reported that during the circumcision, the physician screwed on the clamp tightly.After about 5 minutes, the physician began to trim the foreskin.As he was trimming the foreskin, the clamp slid off.There was a considerable amount of blood.The physician applied pressure for over 20 minutes.A surgical dressing was applied to the site.Subsequently, it was determined that the infant sustained some separation of the ventral at the site of the circumcision.It was decide to treat the infant with (b)(6) ointment and let it heal on its own.

Manufacturer Narrative

The gomco circumcision clamp is made of 4 parts, the nut, the bell, the plate, and the arm.All of these parts are marked with either a g or the name gomco.Our arm has the word gomco on the bottom of it.The arm that was returned as part of the clamp in question has no markings on the bottom and is dimensionally different than a gomco clamp arm.It is an arm from an unknown manufacturer.This clamp did not function properly because a unknown clamp arm was used with the other gomco clamp parts.The gomco clamp instruction state the following: "warning: use only component parts manufactured by "gomco" when assembling this device." warning notices have been posted by both the fda and ecri about problems which can occur, if facilities mix parts of circumcision clamps from different manufacturers when they take the clamp apart for cleaning and sterilization.We do not know why other manufacturers are not marking their clamp parts for identification.Facilities should have procedures in place to keep parts of devices separated from parts of other devices during their cleaning, sterilization and assembly.

• 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 ; 3142681616
• MDR Report Key: 4575402
• MDR Text Key: 18634936
• Report Number: 1924066-2015-00002
• 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: 03/03/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 02-02-0501
• Device Catalogue Number: 02-02-0501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 03/03/2015
• 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): Required Intervention
• Patient Age: 1 DA