KTP LASER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-01-17 for KTP LASER manufactured by Laserscope.

Event Text Entries

[170] Ktp laser was used for breast biopsy. After the procedure (in some cases immediately after/while in others at the time of follow-up) blisters were noted at the incision site. Patient #3 information: 50 years old - female condition code=3 event occurred 12/12/91invalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was multiple patient involvement. Number of patients involved: 2. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: none or unknown. Conclusion: device evaluated and alleged failure could not be duplicated, no failure detected and product within specification. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device use continued with restrictions/limitations. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 334
• MDR Report Key: 334
• Date Received: 1992-01-17
• Date of Report: 1992-01-24
• Date of Event: 1991-08-14
• Report Date: 1992-01-24
• Date Reported to FDA: 1992-01-24
• Date Added to Maude: 1992-04-17
• 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: KTP LASER
• Product Code: LLO
• Date Received: 1992-01-17
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 329
• Manufacturer: LASERSCOPE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-01-17