MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3080SP SURGICAL TABLE

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/29/2021

Event Type  malfunction  

Event Description

On may 17, 2023, steris received a subpoena request for documents associated with an event that involved a 3080sp surgical table where a patient allegedly fell from the table during a procedure.The date of the procedure was (b)(6) 2021.

Manufacturer Narrative

Steris conducted a review of service records for the 3080sp surgical table subject of the reported event which did not reveal any service records on or shortly after the date of event.Service record history indicates that the surgical table received multiple service and preventive maintenance activities since the reported event which confirms the table is still in service and operational.Steris conducted a review of complaint history which did not reveal any complaint records for the 3080sp surgical table subject of the reported event.Should additional information become available regarding the reported event, a follow-up report will be submitted.

• Brand Name: 3080SP SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 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: 17135920
• MDR Text Key: 317241265
• Report Number: 1043572-2023-00114
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1