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

Model Number 5095 Surigical Table

Device Problem Device Handling Problem (3265)

Patient Problem Discomfort (2330)

Event Date 07/19/2022

Event Type  malfunction  

Event Description

The user facility reported that an employee had grabbed a headrest for the 5095 surgical table from their storage area and while transporting the headrest the employee's fingers were pinched.The employee received x-rays and ice was applied.

Manufacturer Narrative

A steris account manager stated that the employee's fingers were pinched between the headrest back siderail and the hydraulic head piece.The steris account manager discussed the reported event with user facility personnel and stated that the employee subject of the reported event panicked when her fingers got pinched and would not allow anyone to touch it in order to release the pressure being applied.No issues were noted with the function or operation of the headrest.The 5095 surgical table operator manual states in the introduction, "important: read this entire manual before attempting to install or operate your surgical table.Ensure all appropriate personnel understand the contents of this manual.Safety precautions and pinch points to be observed when operating and servicing the equipment are included in this manual.Do not operate or service the equipment until you have become familiar with this information." 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 ; 4403927453
• MDR Report Key: 15254624
• MDR Text Key: 305416958
• Report Number: 1043572-2022-00055
• 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
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5095 Surigical Table
• Device Catalogue Number: ST015211002
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Date Device Manufactured: 04/19/2022
• 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