AMSCO 3080RL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-17 for AMSCO 3080RL * manufactured by Steris Corporation.

Event Text Entries

[16796519] Patient having surgery on right leg. Table tilted to left to allow exposure for the surgeon. During the surgery, the team heard velcro on the strap give and patient slid to the floor. When the table was examined after the event, the bolt that supports the tilt mechanism was found to be sheared off.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 662776
• MDR Report Key: 662776
• Date Received: 2005-11-17
• Date of Report: 2005-11-15
• Date of Event: 2005-11-04
• Report Date: 2005-11-15
• Date Reported to FDA: 2005-11-17
• Date Added to Maude: 2006-01-13
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: AMSCO
• Generic Name: SURGICAL TABLE
• Product Code: FQO
• Date Received: 2005-11-17
• Model Number: 3080RL
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 12 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 652184
• Manufacturer: STERIS CORPORATION
• Manufacturer Address: 2720 GUNTER PARK EAST MONTGOMERY AL 36109 US
• Baseline Brand Name: AMSCO 3080RL SURGICAL TABLE
• Baseline Generic Name: SURGICAL TABLES AND ACCESSORIES
• Baseline Model No: 3080RL
• Baseline Catalog No: 2175665
• Baseline ID: BE58-731

Device Sequence Number: 2

• Brand Name: KNEE AND BODY STRAP
• Generic Name: POSITIONING STRAP, VELCRO
• Product Code: ISR
• Date Received: 2005-11-17
• Model Number: *
• Catalog Number: 2023
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 652185
• Manufacturer: KENDALL, A DIVISION OF TYCO HEALTHCARE
• Manufacturer Address: 15 HAMPSHIRE STREET MANSFIELD MA 02048 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-11-17