MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085 SRT SURGICAL TABLE

Device Problem No Apparent Adverse Event (3189)

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

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

The medwatch report did not identify the name or location of the user facility or the serial number of the unit in question.A review of complaints and service requests in this time period found no events which match the received report.The 5085 srt surgical table is equipped with a backup hand control system to be used in case the primary hand control is not working.The 5085 srt surgical table operator manual states (5-22), "the steris 5085 srt surgical table is equipped with a backup hand control system.This system can be actuated at any time and allows table operation in the event of primary control malfunction." a follow-up mdr will be submitted should additional information become available.

Event Description

The user facility reported via user facility medwatch number mw5102878 that they were unable to relock their 5085 srt surgical table and that the hand control required replacement.There was no report of patient involvement.No report of injury.

• Brand Name: 5085 SRT 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 ; 4403927453
• MDR Report Key: 12513031
• MDR Text Key: 272707070
• Report Number: 1043572-2021-00067
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Date Manufacturer Received: 08/23/2021
• 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