MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; SCISSOR,IRIS,SATIN(IS163S)STER

Catalog Number	000000000000066450
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "multiple centurion instruments with rust on them/in the package.".
Additional Manufacturer Narrative
The customer reported finding rust on instrument.A sample was received; medline evaluated the returned samples, reviewed finished good production records, reviewed complaint history/trending, and performed a stock check, which found 2ea with rust that were put on hold for scrap.The reported issue was confirmed; rust was visible in the packaging.The investigation did not find any nonconformances in production records, and noted that the instruments are stored at the customer in a temperature and humidity controlled area; however, it is unknown if the kits experienced a high temperature or high humidity environment when in transit to the customer, and this may indicate that the root cause is related to the vendor, hico, who has been notified of this complaint.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: SCISSOR,IRIS,SATIN(IS163S)STER
• 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: 50807753
• Report Number: 1824619-2026-00075
• Device Sequence Number: 8900650
• Product Code: LRW
• UDI-Device Identifier: 10653160022343
• UDI-Public: 10653160022343
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/17/2026

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: 000000000000066450
• Device Lot Number: 2023022890
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2024
• 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: 02/12/2024
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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