JAKO-KLEINSASSER MICRO-LARYNGEAL SCISSORS * 50-6479

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-07-12 for JAKO-KLEINSASSER MICRO-LARYNGEAL SCISSORS * 50-6479 manufactured by *.

Event Text Entries

[381400] A small piece of the scissor's blade detached from the instrument during a micro direct laryngoscopy procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2515651-2004-00043
MDR Report Key611365
Report Source06
Date Received2004-07-12
Date of Report2004-06-11
Report Date2004-06-11
Date Mfgr Received2004-06-11
Date Added to Maude2005-06-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBRADLEY SEIDEN, MGR.
Manufacturer Street200 PRECISION RD. STE 200
Manufacturer CityHORSHAM PA 19044
Manufacturer CountryUS
Manufacturer Postal19044
Manufacturer Phone2154428892
Manufacturer G1PILLING SURGICAL
Manufacturer Street200 PRECISION RD. STE 200
Manufacturer CityHORSHAM PA 19044
Manufacturer CountryUS
Manufacturer Postal Code19044
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJAKO-KLEINSASSER MICRO-LARYNGEAL SCISSORS
Generic NameMICRO-LARYNGEAL SCISSORS
Product CodeKBM
Date Received2004-07-12
Model Number*
Catalog Number50-6479
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key601161
Manufacturer*
Manufacturer Address* * *
Baseline Brand NameJAKO SCISSORS
Baseline Generic NameLARYNGEAL SCISSOR
Baseline Model No50-6479
Baseline Catalog No50-6479
Baseline Device FamilyMICRO LARYNGEAL SCISSORS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-07-12

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