MAUDE Adverse Event Report: CENTURION CIRCLAMP; CLAMP, CIRCUMCISION

Catalog Number 330CRK

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2023

Event Type  malfunction  

Event Description

Centurioncirclamp with 1.3cm bell reprocessed.Reorder 330crk.Lot 2023092501.Exp 2028-06-30.The bell was checked.When the provider placed the base on the baby and tightened it down, she noticed the base was "flaking" and a silver piece was hanging off the base of the gomco.The bell was fine and nothing noted on it.When she removed the base, small silver flecks were noted.No flakes embedded in skin.No harm.

• Brand Name: CENTURION CIRCLAMP
• Type of Device: CLAMP, CIRCUMCISION
• MDR Report Key: 18290964
• MDR Text Key: 330332031
• Report Number: MW5149006
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 330CRK
• Device Lot Number: 2023092501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White