MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY ORTHO VISION SURGICAL TABLE

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

During the time of the reported event, the table top was level and the patient was secured to the table with restraints and coban tape.User facility personnel heard a "pop" sound as the patient's torso began to shift to the left side of the table.The patient was repositioned on the table and the procedure was completed successfully as no delays or cancellations were reported.A steris service technician arrived onsite to inspect the ortho vision table and found the table to be operating per specifications.The technician confirmed there was no evidence of any hydraulic leaks and did not note any issues with the operation of the table's tilt and lateral translations.The ortho vision table is not under a steris service contract and is maintained by a third-party service provider.In-service training was scheduled for 4/25/2017 however the user facility requested that steris reschedule.Steris account manager has made multiple attempts to reschedule in-service training on the proper use and maintenance of the table with the facility and the facility has not responded.

Event Description

The user facility reported that during a patient procedure, they heard a "popping" noise and the ortho vision table moved without being commanded to do so.The patient did not sustain any injuries.

• Brand Name: ORTHO VISION SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6576993
• MDR Text Key: 75666444
• Report Number: 1043572-2017-00030
• Device Sequence Number: 1
• Product Code: JEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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