FDA Adverse Event Other Summary report: N

*

MDR report key: 1280325 · Received November 4, 2008

Report

Report Number
9610617-2008-00027
Event Type
Other
Date Received
November 4, 2008
Manufacturer
KARL STORZ GMBH & CO. KG
Product Code
FAJ
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

EVAL SUMMARY: THE SUBJECT 27040XB SHEATH IS ABOUT 3 YRS OLD AND WAS RETURNED TO US IN THE FOLLOWING CONDITION: NUMEROUS DENTS ALL OVER THE SHAFT AND A BIG DENT ABOUT 3.2" FROM THE DISTAL END. THE IRRIGATION PORT IS NOT SEATED IN THE CORRECTION ORIENTATION. THE DISTAL END OF THE SHEATH IS CRIMPED AND BENT INTO AN OVAL SHAPE INSTEAD OF CIRCULAR. THE BEAK IS COMPLETELY MISSING, AND THE INNER SURFACE OF THE SHEATH WHERE THE BEAK WAS HAS EPOXY RESIDUALS LEFT IN BOTH WHITISH AND YELLOWISH COLORS, WHICH INDICATES TWO DIFFERENT TYPES OF EPOXY HAVE BEEN USED. ALTHOUGH THE "BROKEN" BEAK WAS NOT RETURNED TO US, IT WAS DESCRIBED TO US AS A WHITE "PLASTIC" RING SHAPED PIECE AND THAT WOULD MEAN: IF MISSING BEAK IS PLASTIC MATERIAL, IT COULD FIT TO THE OVAL SHAPED DISTAL END; IF IT WERE CERAMIC MATERIAL AS OUR ORIGINAL DESIGN, IT WOULD NOT FIT TO THE OVAL SHAPED DISTAL END. IF THE MISSING BEAK IS PLASTIC MATERIAL, IT WOULD HAVE A CLEAN SEPARATION AND LEAVE NO PLASTIC MATERIAL OVER THE INNER SURFACE OF THE DISTAL END; IF IT WERE CERAMIC MATERIAL, THE BREAKAGE WOULD NOT BE CLEAN AND SOME CERAMIC MATERIAL WOULD STILL BE LEFT ON THE INNER SURFACE OF THE DISTAL END. IF THE MISSING BEAK IN THE MIDDLE IS PLASTIC MATERIAL, IT IS SOFTER AND COULD BE REMOVED IN ITS RING SHAPE BY CLAMPING AND REMOVING THROUGH THE SHEATH; IF IT WERE CERAMIC MATERIAL, ONE WOULD HAVE TO BREAK IT (APPROX. 14 MM X 9 MM) IN ORDER TO REMOVE IT FROM THE SHEATH. BASED ON THE ABOVE, WE BELIEVE THE SHEATH HAS BEEN SERVICED BY A THIRD PARTY AND THE BEAK HAS BEEN REPLACED WITH AN UNAUTHORIZED PART.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * * FAJ KARL STORZ GMBH & CO. KG * *

Patients

Seq Age Sex Outcome Treatment
1