inforMED
MalfunctionFBO

INNER SHEATH

Received Jan 17, 2020

Report 9610617-2020-00004 · MDR key 9603154

Device

Generic name

Urology Resectoscope Inner Sheath

Model number

27050CA

Catalog number

27050C

Lot number

NU01

Product problems

  • Material Separation
  • Material Separation

Patient

Not reported

  • Foreign Body In Patient
  • Device Embedded In Tissue or Plaque
  • Foreign Body In Patient
  • Device Embedded In Tissue or Plaque

Narrative

Additional Manufacturer Narrative

PER THE FACTORY, UPON EXAMINATION WE FOUND THAT THE CERAMIC TIP IS BROKEN OFF. THE CERAMIC INSERT HAS NOT BEEN PROVIDED. THERE WAS SUFFICIENT GLUE BETWEEN TIP AND SHEATH, BECAUSE THE BONDED CERAMIC STILL ADHERES WELL IN THE INNER PART OF THE SHEATH. THE SHEATH SHOWS PROXIMAL CORROSION, WHICH CAN BE ATTRIBUTED TO INCORRECT CLEANING. DAMAGES LIKE THIS HAPPEN IF THE CERAMIC TIP IS HIT AGAINST HARD OBJECTS OR EDGES. THE DAMAGE OF THE PRODUCT IS NOT CAUSED BY A PRODUCTION PROBLEM OR MATERIAL DEFECT. HINTS ON HOW TO INSPECT THE CERAMIC TIP ARE ALREADY INCLUDED IN THE IFU.

Description of Event or Problem

PER THE FACTORY IN (B)(4), ALLEGEDLY, THERE WAS AN EVENT OCCURRED IN (B)(6) THAT THE TIP WAS BROKEN OFF DURING AN OPERATION. A SECOND OPERATION WAS NEEDED TO REMOVE THE BROKEN PART.