MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3085 SURGICAL TABLE

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

Contrary to the initial reported event by user facility personnel of the surgical table tipping during transfer, it was confirmed that the table did not tip but rather became unstable due to use of the transfer board.A steris service technician arrived onsite to inspect the surgical table and found it to be operating properly.No issues were noted with the function or operation of the table and the technician was unable to duplicate the reported event.The steris service technician returned the table to service and no additional issues were reported.During the time of the reported event, user facility personnel were utilizing a patient transfer board.The transfer board is only intended to support the legs of a patient.Due to the improper use of the patient transfer board by user facility personnel, the steris service technician counseled user facility personnel on the proper use of the transfer board and the surgical table.The operator manual states, (pp.1-2), "warning-instability hazard: patient transfer board must be used a leg support only.It is not intended to support upper body weight of a patient.".

Event Description

The user facility reported that while the patient was being transferred off the surgical table following the procedure, the surgical table felt unstable.The patient was successfully transferred; no report of injury.

• Brand Name: 3085 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: lyndsey snyder ; 5960 heisley road; mentor, OH 44060 ; 4403927386
• MDR Report Key: 6644867
• MDR Text Key: 77766059
• Report Number: 1043572-2017-00042
• Device Sequence Number: 1
• Product Code: FQO
• 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: 06/15/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/15/2017
• 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