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

Catalog Number 02-01-0500

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure to Anastomose (1028)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

During a typical circumcision procedure on a newborn infant, the gomco circumcision clamp did not clamp down to achieve homeostasis.Two sutures were required as a result.

• Brand Name: GOMCO
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave; st. louis MO 63110
• MDR Report Key: 3644104
• MDR Text Key: 18735051
• Report Number: 3644104
• Device Sequence Number: 1
• Product Code: HFX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/20/2014

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: Physician
• Device Catalogue Number: 02-01-0500
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DAY