MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE

Device Problems Self-Activation or Keying (1557); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility's biomed department inspected the table and determined the wing nuts for the head section were not properly tightened on the head section during the time of the reported event.The biomed department tightened the wing nuts.A steris service technician arrived onsite to inspect the 4085 surgical table.The technician tested the table and found no issues with the function or operation of the table including the head section.The 4085 surgical table operator manual states (1-2), "warning - personal injury hazard: when installing any table accessory, check for correct attachment and tighten securely (if appropriate).Do not use a worn or damaged accessory.Before using any accessory, ensure it has been installed properly." a steris account manager has offered an in-service training on the proper use and operation of the surgical table, specifically properly attaching the head section; the in-service training is scheduled for (b)(6) 2020.No additional issues were reported.

Event Description

The user facility reported that during a procedure with their 4085 surgical table slid fully to the head end, user facility personnel commanded their table to trendelenburg when the head section slid out of position.As the head section slid out of position, the patient began to slide off the table causing the table to tip downwards.The procedure was cancelled after the reported event.No report of injury.

• Brand Name: 4085 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 10555506
• MDR Text Key: 208962909
• Report Number: 1043572-2020-00042
• 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: 08/24/2020

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: 08/24/2020
• Initial Date FDA Received: 09/18/2020
• 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