MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORPORATION CENTURION; CLAMP, CIRCUMCISION

Model Number 310CR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 10/20/2019

Event Type  malfunction  

Event Description

During circumcision: no hemostasis, no closing - clamp removed the foreskin.Centurion was used to circumcise infant by doctor when she closed the clamp, instead of just providing hemostasis, it removed the foreskin from the penis.

• Brand Name: CENTURION
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 301 catrell dr; howell MI 48843
• MDR Report Key: 9693510
• MDR Text Key: 178568687
• Report Number: 9693510
• Device Sequence Number: 1
• Product Code: HFX
• UDI-Device Identifier: 00653160197471
• UDI-Public: (01)00653160197471
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 310CR
• Device Catalogue Number: 310CR
• Device Lot Number: 2019061801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Weight: 3