MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085 SURGICAL TABLE

Device Problems Self-Activation or Keying (1557); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician inspected the surgical table and found it to be operating properly.The technician was unable to duplicate the reported event and no issues were noted.During the steris technician's discussion with facility personnel present during the time of the reported event it was determined that facility personnel turned the locking screws for the headrest in the wrong direction causing the headrest to become loose and disengage.The steris technician instructed user facility personnel of the proper install of the 5085 surgical table's headrest.The operator manual page 5-13 instructs users of the proper install of the 5085 surgical table's head section.The operator manual states (pg.1-2), "when installing any table accessory, check for correct attachment and tighten securely (if appropriate).Do not use a worn or damaged accessory.Check installation before use any accessory." the operator manual states (pg.1-3), "patient or operator injury may result if the operator of this table is not completely familiar with the controls for patient positioning and table operation.".

Event Description

The user facility reported that during a patient procedure the head section's left side on their 5085 surgical table lowered in height.The patient procedure was completed successfully and no injuries were reported.

• Brand Name: 5085 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: 5974058
• MDR Text Key: 55795949
• Report Number: 1043572-2016-00079
• 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: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• 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
• Date Manufacturer Received: 08/26/2016
• 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