CO2 LASER 250Z

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-02 for CO2 LASER 250Z manufactured by Lasersonics.

Event Text Entries

[1099] Patient udergoing diagnostic laparoscopy for pelvic pain. Co2 laser was being used to burn areas of endometriosis. On approximately the second firing, the laser beam "jumped" from the targeted position and burned a small area adjacent to the endonetriosis. Use of the co2 laser was discontinued and the surgeon used electrocautery to finish the case. The laser was test fired prior to the case and was used the day before without incident. Service representatives called the afternoon of 11/12/92 and the laser was taken out of service until cleared by manufacturerdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-aug-92. Service provided by: factory trained/authorized/owned service organization. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, mechanical tests performed. Results of evaluation: design - human factors, anticipated adverse reaction - short term. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1851
• MDR Report Key: 1851
• Date Received: 1992-12-02
• Date of Report: 1992-11-13
• Date of Event: 1992-11-12
• Date Facility Aware: 1992-11-12
• Report Date: 1992-11-13
• Date Reported to FDA: 1992-11-13
• Date Reported to Mfgr: 1992-11-12
• Date Added to Maude: 1992-12-08
• 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: CO2 LASER
• Product Code: HHR
• Date Received: 1992-12-02
• Model Number: 250Z
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1727
• Manufacturer: LASERSONICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-12-02