MAUDE Adverse Event Report: CENTURION CIRCUMCISION SCISSORS; CLAMP, CIRCUMCISION

Lot Number 2020040690

Device Problem Break (1069)

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

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Clamp (stat) broken during circumcision.Circ tray lot 2020040690.No harm to patient.Fda safety report id# (b)(4).

• Brand Name: CIRCUMCISION SCISSORS
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION ; vienna VA 22182
• MDR Report Key: 12085946
• MDR Text Key: 259145685
• Report Number: MW5102176
• Device Sequence Number: 1
• Product Code: HFX
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 2020040690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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