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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/01/2016

Event Type  malfunction  

Event Description

During a circumcision procedure, the physician noted excessive foreskin bleeding after procedure utilizing a gomco style circumcision clamp.Inspection of the circumcision clamp noted than the bell shaft fit loosely to the clamps pivot arm.Clamp removed and sent to biomedical for evaluation.Biomedical inspection noted correct sizing on the bell shaft as well as the clamp plate.Biomedical could not determine sizing of pivot arm or whether this pivot arm was a component part of the circumcision clamp assembly.Biomedical noted that when pivot arm tightening nut was tightened completely down that the pivot arm clearance was flush with plate and bell shaft was still loose to plate.C-clamp sequestered for further evaluation.Biomedical could not determine manufacturer of circumcision clamp pivot arm due to no identifying markings or stamps.

• Brand Name: GOMCO CIRCUMCISION CLAMP
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave.; st. louis MO 63110
• MDR Report Key: 5959395
• MDR Text Key: 55008511
• Report Number: 5959395
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/09/2016

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2016
• 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
• Patient Outcome(s): Other