LASER 8000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-03-02 for LASER 8000 manufactured by Heraeus Lasersonics.

Event Text Entries

[855] On january 10, 1992, a patient underwent surgery for laser ablation of granulation in the trachea. During surgery, a sudden, severe hemorrage occured which was noted to be from innominate artery erosion. Resuscitative measures were carried but were unsuccessful. The patient exsanguinatedinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 316
• MDR Report Key: 316
• Date Received: 1992-03-02
• Date of Report: 1992-02-18
• Date of Event: 1992-01-10
• Report Date: 1992-02-18
• Date Reported to FDA: 1992-02-18
• Date Added to Maude: 1992-04-16
• 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
• Health Professional: 0
• Initial Report to FDA: 0
• 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: LASER
• Generic Name: YAG LASER
• Product Code: LLO
• Date Received: 1992-03-02
• Model Number: 8000
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 311
• Manufacturer: HERAEUS LASERSONICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-03-02