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

Model Number	330CR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A disposable centurion 1.3 clamp was used for a circumcision.When the bell was being removed from the head of the penis, a metal shard adhered to the glans.The ob noted this shard and prevented injury from infant's circumcision.

• Brand Name: CENTURION
• Common Device Name: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION,LP; 301 catrell dr; howell MI 48843
• MDR Report Key: 25485429
• Report Number: 25485429
• Device Sequence Number: 9716527
• Product Code: HFX
• UDI-Device Identifier: 00653160197495
• UDI-Public: 00653160197495
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/08/2026
• Report Date (Section F): 06/08/2026

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
• Operator of Device: Health Professional
• Device Model Number: 330CR
• Device Lot Number: 2026021901
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 06/08/2026