SURGISTOOL 0830000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-15 for SURGISTOOL 0830000000 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[34251197] It was reported that the brake would not function due to the brake tip breaking off from the device. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001831750-2015-00631
• MDR Report Key: 5297549
• Date Received: 2015-12-15
• Date of Report: 2015-11-27
• Date of Event: 2015-11-27
• Date Mfgr Received: 2015-11-27
• Date Added to Maude: 2015-12-15
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. BRIAN THOMPSON
• Manufacturer Street: 3800 EAST CENTRE AVENUE
• Manufacturer City: PORTAGE MI 49002
• Manufacturer Country: US
• Manufacturer Postal: 49002
• Manufacturer Phone: 2693292100
• Manufacturer G1: STRYKER MEDICAL-KALAMAZOO
• Manufacturer Street: 3800 EAST CENTRE AVENUE
• Manufacturer City: PORTAGE MI 49002
• Manufacturer Country: US
• Manufacturer Postal Code: 49002
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SURGISTOOL
• Generic Name: STOOL, OPERATING-ROOM
• Product Code: FZM
• Date Received: 2015-12-15
• Catalog Number: 0830000000
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER MEDICAL-KALAMAZOO
• Manufacturer Address: 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-12-15