COHERENT MEDICAL NOVUS DF *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-31 for COHERENT MEDICAL NOVUS DF * manufactured by Coherent Medical.

Event Text Entries

[123104] Argon laser in use 27 minutes for tympanoplasty when it started smelling like burnt rubber, stopped working properly. Case stopped. Pt will need to be readmitted for repeat surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 145817
• MDR Report Key: 145817
• Date Received: 1997-12-31
• Date of Report: 1997-10-21
• Date of Event: 1997-10-15
• Date Facility Aware: 1997-10-15
• Report Date: 1997-10-21
• Date Reported to Mfgr: 1997-10-21
• Date Added to Maude: 1998-01-28
• 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 Details

• Brand Name: COHERENT MEDICAL
• Generic Name: ARGON LASER
• Product Code: LXR
• Date Received: 1997-12-31
• Model Number: NOVUS DF
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 9 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 142138
• Manufacturer: COHERENT MEDICAL
• Manufacturer Address: 3270 WEST BAYSHORE RD. PALO ALTO CA 94303 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1997-12-31