ND:YAG CL-60 XXX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-10 for ND:YAG CL-60 XXX manufactured by Surgical Laser Technology.

Event Text Entries

[2330] During the performance of a diagnostic laparoscopy with the laser, a laser ablation of endometrosis injury to artery resulted. The injury required a mini laparotomy tobe performed to correct the arterial bleeder. The patient was stable, did well postoperatively and was discharged without incident. The laser handpiece and tip are both manufactured by sltdevice 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-91. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3818
• MDR Report Key: 3818
• Date Received: 1992-07-10
• Date of Report: 1992-01-23
• Date of Event: 1992-01-13
• Date Facility Aware: 1992-01-13
• Report Date: 1992-01-23
• Date Added to Maude: 1993-05-06
• 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
• 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: ND:YAG
• Generic Name: XXX
• Product Code: LLO
• Date Received: 1992-07-10
• Model Number: CL-60
• Catalog Number: XXX
• Operator: OTHER
• Device Availability: Y
• Device Age: 01-MAR-89
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3560
• Manufacturer: SURGICAL LASER TECHNOLOGY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-10