ENDOSTAT 10-0612 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-29 for ENDOSTAT 10-0612 * manufactured by Laserscope Surgical Systems.

Event Text Entries

[22168218] Pt with history of tracheal stenosis and recent tracheostomy underwent bronchoscopy with laser performed with endostat disposable fiber optic laser system. Sustained second degree burns to right side of upper and lower lip, adenoids and vocal cords. Admitted and started on iv decadron and kefzol and topical bacitracin. Unable to tolerate oral feeds and pain managed with mos04 and tylenol. On 6/24/1993 tolerating oral liquids and lip burn healing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 175286
• MDR Report Key: 175286
• Date Received: 1998-06-29
• Date of Report: 1998-06-25
• Date of Event: 1998-06-22
• Date Facility Aware: 1998-06-23
• Report Date: 1998-06-25
• Date Reported to Mfgr: 1998-06-25
• Date Added to Maude: 1998-07-06
• 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: ENDOSTAT
• Generic Name: DISPOSABLE FIBER OPTIC LASER SYSTEM
• Product Code: LLO
• Date Received: 1998-06-29
• Model Number: 10-0612
• Catalog Number: *
• Lot Number: 10-0612 448W
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 170432
• Manufacturer: LASERSCOPE SURGICAL SYSTEMS
• Manufacturer Address: 3052 ORCHARD DR SAN JOSE CA 951342011 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1998-06-29