MAUDE Adverse Event Report: MIZUHO OSI COUPLER II MAIN ASSEMBLY; OPERATING TABLE, PRODUCT CODE: JEA

Model Number	5873
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mayfield slipped during patient transfer resulting in a cut on the patient's head and the coupler ii device was somehow involved in the incident.
Event or Problem Description
It was reported that a mayfield slipped during patient transfer resulting in a cut on the patient's head and the coupler ii device was somehow involved in the incident.
Additional Manufacturer Narrative
After investigation, it was found out that the coupler ii did not contribute to the incident and injury was related to the mayfield skull clamp (concomitant product) which is not manufactured by mizuho osi.

• Brand Name: COUPLER II MAIN ASSEMBLY
• Common Device Name: OPERATING TABLE, PRODUCT CODE: JEA
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 14778107
• Report Number: 2921578-2022-00008
• Device Sequence Number: 5936349
• Product Code: JEA
• UDI-Device Identifier: 00842430104534
• UDI-Public: 00842430104534
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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: 5873
• Device Catalogue Number: 5873
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MAYFIELD SKULL CLAMP; MAYFIELD SKULL CLAMP
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown