STERIS OT-1100 FRACTURE TABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-16 for STERIS OT-1100 FRACTURE TABLE manufactured by Steris Corp..

Event Text Entries

[97715670] An orthopedic surgeon was utilizing a steris ot-1100 fracture table during a surgical procedure. Prior to commencing the surgery, the fracture table had been set to the height and angle requested by the surgeon. During the surgery, the fracture table tilted downward at the lower end of the table. None of the surgery personnel witnessed the movement of the table. Adjustments to the height and position of the table are made using the handheld control which is attached to the table via cord. None of the personnel were operating the handheld control at the time of the incident. The device manufacturer was contacted and sent a service technician to inspect the fracture table. After a thorough inspection, no issues were identified which would have resulted in movement of the table (i. E. Hydraulic leak). The service technician could not get the fracture table to repeat the incident during his inspection. It was noted that the handheld control showed some damage. The handheld remote was replaced prior to placing the fracture table back in service.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5074597
• MDR Report Key: 7199595
• Date Received: 2018-01-16
• Date of Report: 2018-01-12
• Date Added to Maude: 2018-01-17
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: STERIS OT-1100 FRACTURE TABLE
• Generic Name: TABLE, SURGICAL
• Product Code: JEB
• Date Received: 2018-01-16
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STERIS CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-01-16