MAUDE Adverse Event Report: MIZUHO OSI TABLE, HANA, 110 V; OPERATING TABLE

Model Number	6875
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient developed compartment syndrome in buttock after surgery to repair femur fracture.Hana table was used with bilateral traction boots and scissoring leg position.Reported in "contralateral gluteal compartment syndrome after prolonged use of a fracture table in a scissoring position - a case report" by jenna gunn et al.Jbjs case connector 13(3):e23.00095, july-september 2023.| doi: 10.2106/jbjs.Cc.23.00095 https://journals.Lww.Com/jbjscc/abstract/2023/09000/contralateral_gluteal_compartment_syndrome_after.7.Aspx.
Additional Manufacturer Narrative
Literature citation: gunn, jenna l.Bs; yatsonsky, david md; pasquinelly, adam bs; kosco, ethan bs; schwartz, tyler g.Bs; sanford, christopher md; georgiadis, gregory m.Md.Contralateral gluteal compartment syndrome after prolonged use of a fracture table in a scissoring position: a case report.Jbjs case connector 13(3):e23.00095, july-september 2023.| doi: 10.2106/jbjs.Cc.23.00095.
Additional Manufacturer Narrative
Based on the information received by one of the physicians involved during the incident, there was no problem with the device or the way it was used.The cause of the development of the compartment syndrome remains inconclusive as authors believe that additional factors such as hemilithotimy positioning, male sex, elevated bmi, displaced femur fractures and prolonged extension of opposite hip may have contributed to the development of the compartment syndrome.Literatue citation: gunn, jenna l.Bs; yatsonsky, david md; pasquinelly, adam bs; kosco, ethan bs; schwartz, tyler g.Bs; sanford, christopher md; georgiadis, gregory m.Md.Contralateral gluteal compartment syndrome after prolonged use of a fracture table in a scissoring position: a case report.Jbjs case connector 13(3):e23.00095, july-september 2023.| doi: 10.2106/jbjs.Cc.23.00095.
Event or Problem Description
Patient developed compartment syndrome in buttock after surgery to repair femur fracture.Hana table was used with bilateral traction boots and scissoring leg position.Reported in "contralateral gluteal compartment syndrome after prolonged use of a fracture table in a scissoring position - a case report" by jenna gunn et al.Jbjs case connector 13(3):e23.00095, july-september 2023.| doi: 10.2106/jbjs.Cc.23.00095 https://journals.Lww.Com/jbjscc/abstract/2023/09000/contralateral_gluteal_compartment_syndrome_after.7.Aspx.

• Brand Name: TABLE, HANA, 110 V
• 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 ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 17647399
• Report Number: 2921578-2023-00014
• Device Sequence Number: 6154525
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Literature,Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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: 6875
• Device Catalogue Number: 6875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/20/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2014
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Race: White