MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY FEATHERWEIGHT LEG SECTION TO 5085 SURGICAL TABLE

Device Problem Collapse (1099)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

Contrary to the reported event, the surgical table did not collapse but rather, the featherweight leg section detached and fell from the table.During patient set-up the featherweight leg section was not properly installed on the end of the surgical table resulting in the reported event.As the featherweight leg section detached during the procedure the surgeon stepped backwards to avoid contacting the leg section, however, he lost his balance on an object behind him and fell to the floor.A steris service technician arrived on-site to inspect the surgical table and featherweight leg section accessory.He tested the table's function and articulations and was unable to duplicate the reported event.Furthermore, the technician was able to successfully install and de-install the featherweight leg section subject of the event.The reported event can be attributed to user error as the leg section accessory was not properly installed upon the end of the table.The technician counseled user facility personnel on the proper use and operation of the table and leg section accessory.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure their 5085 surgical table "collapsed", injuring a surgeon.Report of procedure delay as the surgeon had to re-scrub.No medical treatment was sought or administered.There was no injury to the patient and the procedure was completed successfully.

• Brand Name: FEATHERWEIGHT LEG SECTION TO 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7932032
• MDR Text Key: 122659221
• Report Number: 1043572-2018-00077
• 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: 10/03/2018

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: 09/04/2018
• Initial Date FDA Received: 10/03/2018
• 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