SHARPLAN 1060 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-29 for SHARPLAN 1060 * manufactured by Sharplan.

Event Text Entries

[70419] Pt. Has history of vocal cord carcinoma treated previously with radiation therapy and laser ablation. Had been left with scar tissue web between vocal cords. To surgery for laser division of laryngeal web. This pt was identified in the holding area and taken to the operating room. He was placed supine on the operating room table and general endotracheal anesthesia was induced. The table was turned 90 degrees and a laryngoscope was introduced into the pt's oral cavity. This was suspended from laser arm with sharplan laser set on 5 watts and attached to micro manipulator. Anterior vocal cord web was divided in a posterior to anterior direction, however, very shortly after beginning division of the vocal cord web, during which time only about 1 mm of web had been divided, laser tube was struck with a brief laser burst and immediately caught fire. A large amount of smoke began issuing forth from endotracheal tube which was removed as quickly as possible and pt's oral cavity was filled with water. This was then suctioned clear and a new endotracheal tube was placed. Pt was ventilated through this while rigid bronchoscopy was brought in. Ventilating bronchoscope was used and it was seen that there were some pieces of ash in pt's posterior trachea; these were removed with forceps and trachea was lavaged with normal saline which was then suctioned clear. There was no full thickness mucosal burns, there were simply superficial burns of the proximal trachea. Pt was then extubated, awakened and transferred to floor. He was in stable condition and required substantial amounts of supplemental oxygen to maintain oxygen saturation in mid 90s.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number124328
MDR Report Key124328
Date Received1997-09-29
Date of Report1997-09-23
Date of Event1997-09-15
Date Facility Aware1997-09-15
Report Date1997-09-28
Date Reported to FDA1997-09-29
Date Reported to Mfgr1997-09-29
Date Added to Maude1997-10-07
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSHARPLAN
Generic NameC02 LASER
Product CodeEWG
Date Received1997-09-29
Model Number1060
Catalog Number*
Lot Number*
ID NumberCONTROL # S/N 01-045
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key121729
ManufacturerSHARPLAN
Manufacturer Address1 PEARL CT. ALLENDALE NJ 07401 US


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Hospitalization 1997-09-29

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