inforMED
MalfunctionFBO

INNER TUBE WITH CERAMIC BEAK

Received Jun 28, 2019 · Event occurred Apr 16, 2019

Report 9610617-2019-00053 · MDR key 8745298

Device

Generic name

Inner Tube With Ceramic Beak

Model number

27050XB

Catalog number

27050XB

Lot number

NS01

Product problems

  • Material Separation
  • Material Separation

Patient

78 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

WE EVALUATED THE INNER TUBE AND FOUND A PORTION OF THE CERAMIC BEAK IS BROKEN OFF, THERE ARE TOOL MARKS ON THE DISTAL END OF METAL SHAFT NEAR THE BEAK, AND THE SHAFT IS DENTED. IN ADDITION, WE FOUND THAT THIS INNER TUBE HAS BEEN 3RD PARTY REPAIRED; THE CERAMIC BEAK IS WHITE WHEN IT SHOULD BE GRAY IN COLOR, AND THE CERAMIC MATERIAL IS THINNER THAN OUR GRAY CERAMIC MATERIAL. THE MOST LIKELY CAUSE OF THIS TYPE OF BREAKAGE OF THE CERAMIC BEAK IS MECHANICAL FORCE.

Description of Event or Problem

ALLEGEDLY, A PORTION OF THE INNER TUBE'S CERAMIC BEAK BROKE DURING A TURBT PROCEDURE; THE BROKEN PIECE WAS SUBSEQUENTLY FOUND IN A SPECIMEN CUP BY THE LAB.