MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5095 SURGICAL TABLE

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation of the reported event is in process.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that during a patient procedure, their 5095 surgical table "stopped working".No report of injury.

Manufacturer Narrative

Through follow up, the user facility stated that the procedure was completed successfully.The user facility also stated that the table would not respond to hand control commands.The user facility utilized the back-up hand controls to complete the procedure.The 5095 surgical table subject of the reported event was returned to steris for evaluation.The evaluation determined that the table had torn bellows and a bent bellow frame.As the table had a bent bellow frame, the table was unable to lower to its lowest height.The customer was provided with a replacement table.No additional issues have been reported.

• Brand Name: 5095 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: 17769492
• MDR Text Key: 323660319
• Report Number: 1043572-2023-00138
• Device Sequence Number: 1
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: 00724995195649
• 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,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• 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