MAUDE Adverse Event Report: STERIS CORPORATION; SHROUDGUARD COLUMN PROTECTORS

Model Number	SHROUDGUARD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The shroudguard column protectors subject of the reported event are being returned to steris for evaluation.Our investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available.Udi related data clarification - the lot number is unknown; therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that an employee obtained a cut when removing the shroudguard column protectors from their surgical table.No medical treatment was sought or administered.
Additional Manufacturer Narrative
Contrary to the initial report, the shroud guard column protectors were discarded and were not returned for evaluation.Without the returned device, the cause of the reported event cannot be determined.All current on-hand inventory was inspected.Steris was unable to confirm or duplicate the reported issue.A 3-year complaint review indicates this to be an isolated event.The user facility was provided with a replacement shroud guard column protectors.The user facility provided four serial numbers that were associated with the complaint (b)(6).No additional issues have been reported.

• Brand Name: NA
• Common Device Name: SHROUDGUARD COLUMN PROTECTORS
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 22385460
• Report Number: 1043572-2025-00058
• Device Sequence Number: 9075664
• Product Code: GDC
• UDI-Device Identifier: 00724995203290
• UDI-Public: (01)00724995203290(11)240703
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SHROUDGUARD
• Device Catalogue Number: BF069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown