OLYMPUS A5578 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-10-27 for OLYMPUS A5578 NA manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[169270] A hosp bio-medical technician (bmt) reported that the tip of a reusable a5578 spatula electrode separated from the instrument shaft and fell into the pt's chest cavity during a thoroscopy procedure. The surgeon retrieved the piece and the procedure was completed without complications.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610773-2000-00038
MDR Report Key302864
Report Source07
Date Received2000-10-27
Date of Report2000-09-28
Date Mfgr Received2000-09-28
Date Added to Maude2000-11-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 Location0
Manufacturer ContactLAURA STORMS-TYLER
Manufacturer Street2 CORPORATE CENTER DR
Manufacturer CityMELVILLE NY 11747
Manufacturer CountryUS
Manufacturer Postal11747
Manufacturer Phone6318445688
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOLYMPUS
Generic NameSPATULA ELECTRODE
Product CodeEWY
Date Received2000-10-27
Model NumberA5578
Catalog NumberNA
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key293143
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG GM 22045
Baseline Brand NameOLYMPUS
Baseline Generic NameSPATULA ELECTRODE
Baseline Model NoA5578
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK912362
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2000-10-27

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