UROLASE N/A 350000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-05-24 for UROLASE N/A 350000 manufactured by Bard Urological Division.

Event Text Entries

[16364772] During a laser turp procedure the laser probe tip broke away fromthe lead cable. The lead cable was removable via the cystoscope of residual material in the patient while the probe tip required removal with a rigid forcep. As described by the circulatory nurse on duty: "the physician first noticed the failure when the probe tip did not glow as was normal, he then realized that the probe tip had become detached from the lead cable inside the patient". The patient did not suffer any residual injury and the procedure was completed using a replacement cable/probe assembly. The device in question was kept in surgery awaiting a visit from the manufacturer's representativedevice labeled for single use. Patient medical status prior to event: satisfactory condition. 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. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure, manufacturing, material degradation/deterioration, telemetry failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6033
• MDR Report Key: 6033
• Date Received: 1993-05-24
• Date of Report: 1993-04-27
• Date of Event: 1993-04-24
• Date Facility Aware: 1993-04-24
• Report Date: 1993-04-27
• Date Reported to FDA: 1993-04-27
• Date Reported to Mfgr: 1993-04-26
• Date Added to Maude: 1993-08-02
• 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: UROLASE
• Generic Name: RIGHT ANGLE LASER FIBER
• Product Code: GDB
• Date Received: 1993-05-24
• Model Number: N/A
• Catalog Number: 350000
• Lot Number: 7592
• ID Number: N/A
• Device Expiration Date: 1996-11-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5728
• Manufacturer: BARD UROLOGICAL DIVISION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-05-24