MAUDE Adverse Event Report: MIZUHO OSI LEVÓ DUAL MOTION BASE, REFURBISHED; OPERATING TABLE

Model Number	7887-010R
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During patient positioning the levo dual motion base was slipping in the longitudinal direction while locked.It was especially noticeable when the patient was in reverse trendelenburg position.
Additional Manufacturer Narrative
Following the evaluation of the returned device, it was found that the internal components (cams) were improperly installed during the assembly process and did not fully engage with the gear racks when the brake handles were in locked position.An additional space was created between the tooth locks and gear rack as a result of improper installation causing the longitudinal slip motion of the device.A replacement device with correct assembly/installation of the components was provided to the customer.
Event or Problem Description
During patient positioning the levo dual motion base was slipping in the longitudinal direction while locked.It was especially noticeable when the patient was in reverse trendelenburg position.

• Brand Name: LEVÓ DUAL MOTION BASE, REFURBISHED
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 16015248
• Report Number: 2921578-2022-00026
• Device Sequence Number: 20666286
• Product Code: JEA
• UDI-Device Identifier: 00842430108419
• UDI-Public: 00842430108419
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7887-010R
• Device Catalogue Number: 7887-010R
• Device Lot Number: MIZ220830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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