MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA OPERATING ROOM TABLE; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number 6875

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Anxiety (2328); Complaint, Ill-Defined (2331); Numbness (2415); Sleep Dysfunction (2517)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

We the manufacturer of the table was notified that a surgical procedure was stopped due to multiple complications with surgical equipment for imaging and traction (trocars, sheaths, endoscopes, surgical tabletop).During the surgical procedure, it was found that the surgical staff was having difficulty imaging the surgical area using the stryker endoscope, after repeated attempts with the scope and pivoting cannula, poor irrigation and aspiration through the cannula, and the scope was replaced for alternative scopes.Ultimately leading up to the same issue associated to poor imaging results.After repeated failures of the scopes, traction had been adjusted with the pt's leg in different positions and after 120 mins of traction the surgical table's tabletop's perineal post receptical had failed causing a loss in traction.At this time, the surgical procedure was stopped due to multiple complications with surgical equipment (cannulas, sheaths, endoscopes, surgical table top).No injury was noted at the time of the event.The pt later contacted the manufacturer about his inability to sleep, anxiety, pain and numbness in his groin, buttocks in his left leg.Additionally, the pt is stating that the hosp is stating that he is suffering from pudendal nerve palsy due to prolonged traction.

Manufacturer Narrative

The root cause for the table damage could not be determined due to lack of evidence.No photos or other evidence was submitted by the facility.The facility replaced the table top and disposed of the damaged one before any investigation by the manufacturer could occur.We were unable to evaluate the possible relationships between the use of the table, the table damage, and the patient's various illnesses.Device not returned.

• Brand Name: HANA OPERATING ROOM TABLE
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 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: anne leblanc ; 30031 ahern av; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 4638803
• MDR Text Key: 5598501
• Report Number: 2921578-2015-00005
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 6875
• Device Catalogue Number: 6875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 03/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2007
• 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
• Treatment: STRYKER ENDOSCOPE 70 DEGREE; NITONAL WIRE; ARTHREX HIP SET LONG NEEDLE
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR