OLYMPUS A2636 83A2636

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-04-24 for OLYMPUS A2636 83A2636 manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[7772969] Upon eval, the mfr found that the epoxy cement used to secure an internal screw in the deflecting tip of the obturator had deteriorated over time. This allowed the screw to shift, and as a result, the obturator locked in a deflected position. To counter this phenomenon, the mfr has validated a change to a laser welding process.
Patient Sequence No: 1, Text Type: N, H10


[15485711] The customer returned 2 obturators to co's repair facility, because the devices locked in an angulated position.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610773-1998-00006
MDR Report Key164787
Report Source05
Date Received1998-04-24
Date of Report1998-04-06
Date Mfgr Received1998-03-20
Date Added to Maude1998-04-29
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
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameOLYMPUS
Generic NameOBTURATOR, 2
Product CodeFEC
Date Received1998-04-24
Model NumberA2636
Catalog Number83A2636
Lot Number73W, 74W
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key160397
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG GM 22045
Baseline Brand NameOLYMPUS
Baseline Generic NameOBTURATOR
Baseline Model NoA2636
Baseline Catalog No83A2636
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK931995
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-04-24

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