MAUDE Adverse Event Report: MIZUHO OSI MTS SPINAL SURGERY TOP; OPERATING TABLE

Model Number 5943

Device Problems Loss of or Failure to Bond (1068); Crack (1135)

Patient Problem Fall (1848)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that during surgery the carbon from the metal end of the table top came apart causing the patient to fall.One of the doctors caught the patient's head and there were currently no known injuries observed.There were no treatments or extended stay needed for the patient.Point of contract stated there was a 1' crack on the carbon, and they removed it from service.

Event Description

It was reported that during surgery the carbon from the metal end of the table top came apart causing the patient to fall.One of the doctors caught the patient's head and there were currently no known injuries observed.There were no treatments or extended stay needed for the patient.Point of contract stated there was a 1' crack on the carbon, and they removed it from service.

Manufacturer Narrative

Based on the limited available information and per the analysis of internal historical data pertaining to the product, it was found that there were no preventative maintenance checks performed from manufacturer's end.Internal records show that only one table was delivered to this facility in the year 2004 and hence, we suspect that the spine top joints may have disbonded due to aging and corrosion.

• Brand Name: MTS SPINAL SURGERY TOP
• Type of Device: 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 avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 15364355
• MDR Text Key: 305808588
• Report Number: 2921578-2022-00019
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430105982
• UDI-Public: 00842430105982
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5943
• Device Catalogue Number: 5943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other