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

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 4085 surgical table and found that one of the table's floor locks had a broken foot.This prevented the floor locks from making contact with the floor subsequently causing the table to remain unlocked and the reported event to occur.The root cause of the reported event is attributed to user facility personnel damaging the foot of the floor lock.The 4085 surgical table operator manual states (1-4), "caution - possible equipment damage: when moving the table to or from point of use, roll it carefully at moderate speed and only over smooth floors.Maximum floor clearance is 1/4" (6.4 mm).Avoid door and elevator jambs, and obstructions greater than 1/4" (6.4 mm).If necessary, lift table over obstructions, onto trucks, etc.Lift table evenly and only by the table base." the technician replaced the floor lock, tested the table, confirmed it to be operating according to specifications, and returned it to service.The technician counseled facility personnel on the proper use and operation of the 4085 surgical table, specifically properly moving the table to or from point of use.No additional issues have been reported.

Event Description

The user facility reported that during patient transfer at the end of the procedure, their 4085 surgical table would not lock.The table was stabilized by facility personnel and the patient was transferred from the table.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
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 10254881
• MDR Text Key: 207003038
• Report Number: 1043572-2020-00029
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• 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: 06/09/2020
• 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