MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORP. GOMCO CENTURION CIRCLAMP WITH 1.1CM BELL; CLAMP, CIRCUMCISION

Catalog Number 310CR

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2019

Event Type  malfunction  

Event Description

Gomco clamp did not fully clamp when performing circumcision.Fda safety report id # (b)(4).

• Brand Name: GOMCO CENTURION CIRCLAMP WITH 1.1CM BELL
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORP. ; williamston MI 48895
• MDR Report Key: 9028851
• MDR Text Key: 158738133
• Report Number: MW5089771
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/10/2019

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 310CR
• Device Lot Number: 2019053001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 DA