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

Catalog Number 02-00-0500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Manufacturer Narrative

Clamp involved was not returned for evaluation.Pictures of clamp involved do not show the size or a g stamped on the bell/stud.Hospital confirmed that there was no marking on the bell/stud.The other three parts of the clamp had proper gomco markings on them.This indicates the bell/stud was probably from a different manufacturer.Parts from clamps of different manufacturers may have been mixed during the cleaning process.We have no control over dimensions of copy cat parts made by other manufacturers.The clamp instruction manual states the following: warnings: 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 indicating the surgical procedure, you must insure that expected clamping functionals been properly achieved.Use only components 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.

Event Description

It was reported that a male infant undergoing circumcision with a gomco 1.1 cm clap.According to physician, the device did not appear to crimp down enough to seal the foreskin, causing more bleeding than normal.Added pressure to site and monitored to ensure hemostasis.Infant did not have a prolonged stay and was discharged without complications.

• Brand Name: GOMCO
• 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 ; 3147712400
• MDR Report Key: 7753842
• MDR Text Key: 116599852
• Report Number: 1924066-2018-00003
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): Y
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02-00-0500
• Device Lot Number: 8-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention