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

Model Number	5095 Surigical Table
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1043572-2022-00055
• Device Sequence Number: 6672702
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: 00724995195649
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

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: 5095 Surigical Table
• Device Catalogue Number: ST015211002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/18/2022
• Date Device Manufactured: 04/19/2022
• 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