*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-06 for * manufactured by Laserscope.

Event Text Entries

[755248] Laserscope fiber tip broke off during laser prostatectomy inside patient bladder. Doctor removed the broken tip with grasping forceps while visualizing with camera.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number975902
MDR Report Key975902
Date Received2007-12-06
Date of Report2007-12-06
Date of Event2007-11-30
Report Date2007-12-06
Date Reported to FDA2007-12-06
Date Added to Maude2008-01-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameFIBER, LASER
Product CodeLNK
Date Received2007-12-06
Model Number*
Catalog Number*
Lot Number10-2090-731G
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key943919
ManufacturerLASERSCOPE
Manufacturer Address3070 ORCHARD DRIVE SAN JOSE CA 95134 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-12-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.