MAUDE Adverse Event Report: STERIS CORPORATION SHROUDGUARD COLUMN PROTECTOR; SURGICAL TABLE COLUMN PROTECTOR

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	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.The devices subject of the reported event will be returned to steris montgomery for evaluation.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that staff members are injuring themselves (obtaining cuts) when removing the shroudguard column protectors from the surgical tables for cleaning.It is unknown whether medical treatment was sought or administered.
Additional Manufacturer Narrative
The shroudguard column protectors subject of the reported event were returned to steris for evaluation.The evaluation revealed that the protectors were bent and damaged which likely contributed to the reported event.The cause of the observed damage could not be determined.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: SHROUDGUARD COLUMN PROTECTOR
• Common Device Name: SURGICAL TABLE COLUMN PROTECTOR
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19558863
• Report Number: 1043572-2024-00041
• Device Sequence Number: 17356194
• Product Code: GDC
• UDI-Device Identifier: 00724995203283
• UDI-Public: (01)00724995203283(11)220427(21)220427001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/18/2024

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: BF068
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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