FDA Adverse Event Malfunction Summary report: N

UROLASE RIGHT ANGLE LASER FIBER

MDR report key: 7260 · Received November 5, 1993

Report

Report Number: 33467-1993-00007
Event Type: Malfunction
Date Received: November 5, 1993
Date of Event: October 15, 1993
Report Date: October 26, 1993
Manufacturer: TRIMEDYNE, INC.
Product Code: LWX
Product Problem: Yes
Report Source: Distributor report
Reporter Location: PA, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UROLASE RIGHT ANGLE LASER FIBER	LASER FIBER	LWX	TRIMEDYNE, INC.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other