MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; CIRCUMCISION TRAY

Catalog Number	CIT2390
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that scissors malfunctioning, broke during use.
Additional Manufacturer Narrative
The customer/reporter described scissors malfunctioning, broke during use, and the account reported finding hemostats broke.A photo was received for the investigation; one photo showed the hemostat intact, with no defects to note, and the second photo showed one used hemostat with a broken jaw, with the jaw completely detached from the rest of the instrument and the hemostat hinge near where the jaw broke appearing jagged.The reported issue was confirmed.Hemostat item mhs102 is not altered before being placed into the kit after it is received from the supplier/vendor, and the root cause is related to an error in the component manufacturing process; there was no confirmed medical intervention or serious injury reported related to this incident.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: CENTURION
• Common Device Name: CIRCUMCISION TRAY
• Manufacturer (Section D): Centurion Medical Products, LP; 301 catrell drive; howell MI 48843 -170
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883611
• Report Number: 1824619-2026-00097
• Device Sequence Number: 21521188
• Product Code: OHG
• UDI-Device Identifier: 00653160028805
• UDI-Public: 00653160028805
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Device Catalogue Number: CIT2390
• Device Lot Number: 24DBT152
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown