MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TRIOS; OPERATING SURGICAL TABLE

Model Number	7803
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Using a trios surgical table the customer was using the extendable traction unit to apply 15-lbs of weight to the patient's head.A hospital staff member accidentally pressed the release button for the traction assembly causing it to retract and dropping the weights about 4-in.I am told that if a doctor wasn't holding the patient's head it could have been a serious issue.From what i was told there was no injuries caused to the patient.
Additional Manufacturer Narrative
Conclusion for this event is user error as the release button for the traction assembly is not easily pressed when the assembly is in its extended position for use.Initial reporter name and address: corrected information.
Event or Problem Description
Using a trios surgical table the customer was using the extendable traction unit to apply 15lbs of weight to the patients head.A hospital staff member accidentally pressed the release button for the traction assembly causing it to retract and dropping the weights about 4in.I am told that if a doctor wasn't holding the patients head it could have been a serious issue.From what i was told there was no injuries caused to the patient.
Additional Manufacturer Narrative
Conclusion for this event is user error as the release button for the traction assembly is not easily pressed when the assembly is in its extended position for use.
Event or Problem Description
Using a trios surgical table the customer was using the extendable traction unit to apply 15lbs of weight to the patients head.A hospital staff member accidentally pressed the release button for the traction assembly causing it to retract and dropping the weights about 4in.I am told that if a doctor wasn't holding the patients head it could have been a serious issue.From what i was told there was no injuries caused to the patient.

• Brand Name: TRIOS
• Common Device Name: OPERATING SURGICAL TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8961685
• Report Number: 2921578-2019-00034
• Device Sequence Number: 11380610
• Product Code: JEA
• UDI-Device Identifier: 00842430103957
• UDI-Public: 00842430103957
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2019

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: 7803
• Device Catalogue Number: 7803
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 08/22/2019; 08/22/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 10/04/2019; 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1