MAUDE Adverse Event Report: MIZUHO OSI 5321G; OPERATING TABLE

Model Number	5321G
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Blister (4537)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pads on their wilson frame were installed in wrong direction.Customer stated they placed patient onto wilson frame where part of the patient's chest was sitting on no padding for the duration of surgery which was approximately 5 hours.When they removed patient they discovered blisters and bruising.They treated patient by wrapping the affected area.
Event or Problem Description
It was reported that the pads on their wilson frame were installed in wrong direction.Customer stated they placed patient onto wilson frame where part of the patient's chest was sitting on no padding for the duration of surgery which was approximately 5 hours.When they removed patient they discovered blisters and bruising.They treated patient by wrapping the affected area.
Additional Manufacturer Narrative
Based on the information received from the investigation, it was deemed as an user error as the pads were not installed correctly contrary to the instructions per the ifu prior to the use on patient.An in-service training was scheduled for the hospital personnel regarding correct placement of the pads per the ifu.

• Brand Name: 5321G
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenueq; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 15328666
• Report Number: 2921578-2022-00015
• Device Sequence Number: 6484950
• Product Code: JEA
• UDI-Device Identifier: 00842430104459
• UDI-Public: 00842430104459
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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: 5321G
• Device Catalogue Number: 5321G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male