HOLMIUM BARE SINGLE-USE LASER ACCESORY HB-200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-04 for HOLMIUM BARE SINGLE-USE LASER ACCESORY HB-200 manufactured by Laser Peripherals.

Event Text Entries

[637908] Approximately one cm of the holmium laser fiber tip broke off in the patient's bladder. The piece was retrieved by the surgeon.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number846728
MDR Report Key846728
Date Received2007-05-04
Date of Report2007-05-04
Date of Event2007-03-20
Report Date2007-05-04
Date Reported to FDA2007-05-04
Date Added to Maude2007-05-14
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 NameHOLMIUM BARE SINGLE-USE LASER ACCESORY
Generic NameLASER FIBER
Product CodeLNK
Date Received2007-05-04
Model NumberHB-200
Catalog NumberHB-200
Lot NumberLP-414
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Age1 DY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key833858
ManufacturerLASER PERIPHERALS
Manufacturer Address1000 BOONE AVE NORTH SUITE 300 GOLDEN VALLEY MN 55427 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-05-04

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