BARD 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 1992-11-20 for BARD UROLASE RIGHT ANGLE LASER FIBER 350000 manufactured by Trimedyne, Inc..

Event Text Entries

[17485039] It was reported that tweny-five seconds into a lasting procedure of soft tissue ablation, the doctor lost site of the laser fiber tip. The doctor continued to lase for approximately thirty seconds after losing site of the fiber tip. Upon removal of the fiber from the patient, a portion of the fiber tip was noted to be missing. Grasping forceps were inserted through the previously placed scope and the piece was retreived as described in the product labeling. Since the possibility existed that the doctor could have been lasing for approximately thirty seconds in a straight forward direction, a rectal exam was performed to ensure that the patient's prostate and rectum had not been damaged by the procedure. There was no reports of injury to either of these area and no further complications reporteddevice labeled for single use. 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. Invalid data - regarding whether event presents imminent hazard. 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: 33467-1992-00004
• MDR Report Key: 1931
• Date Received: 1992-11-20
• Date of Report: 1992-11-04
• Date of Event: 1992-10-28
• Date Facility Aware: 1992-11-02
• Report Date: 1992-11-04
• Date Reported to FDA: 1992-11-04
• Date Reported to Mfgr: 1992-11-04
• Date Added to Maude: 1992-12-17
• 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: BARD UROLASE RIGHT ANGLE LASER FIBER
• Generic Name: LASER FIBER
• Product Code: LWX
• Date Received: 1992-11-20
• Catalog Number: 350000
• ID Number: 021992110005
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 1800
• Manufacturer: TRIMEDYNE, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-11-20