UROLASE RIGHT ANGLE LASER FIBER 350000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-05 for UROLASE RIGHT ANGLE LASER FIBER 350000 manufactured by Trimedyne, Inc..

Event Text Entries

[4717] It w3as reported that during a laser procedure, the fiber tip seperated at the area where the tip is crimped to the fiber. The event occurred on the third sixty-secocnd laser application at 60 watts. The tip was retreived using grasping forceps through the previously placed scope as described in the product labeling. The procedure was completed with a second fiber and no further complication were reported. It was also reported that two laser fibers from a competitor was used prior to the use of the urolase fibers with unsuccessful results. Invalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. There was not 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. 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: yes. 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: 33467-1993-00007
• MDR Report Key: 7260
• Date Received: 1993-11-05
• Date of Report: 1993-10-26
• Date of Event: 1993-10-15
• Date Facility Aware: 1993-10-20
• Report Date: 1993-10-26
• Date Reported to FDA: 1993-10-26
• Date Reported to Mfgr: 1993-10-21
• Date Added to Maude: 1994-01-13
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• 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: UROLASE RIGHT ANGLE LASER FIBER
• Generic Name: LASER FIBER
• Product Code: LWX
• Date Received: 1993-11-05
• Catalog Number: 350000
• Lot Number: UNKNOWN
• ID Number: 021993100126
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6941
• Manufacturer: TRIMEDYNE, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-11-05