inforMED
InjuryFEC

27/28FR RESECTOSCOPE TIMBERLAKE OBTURATOR

Received Mar 24, 2009 · Event occurred Feb 23, 2009

Report 2936485-2009-00024 · MDR key 1351667

Device

Generic name

Obturator

Catalog number

0502880425

Lot number

UNK

Product problems

  • Other (for use when an appropriate device code cannot be identified)

Patient

UNK

  • Dural Tear
  • Abrasion

Narrative

Description of Event or Problem

IT WAS REPORTED THAT PERFORATION HOLES AT THE END OF THE RESECTOSCOPE PERFORM LIKE A CHEESE GRATER. ALLEGEDLY, THE RIDGE AT THE END OF THE TIMBERLAKE IS CAUSING ABRASIONS AND SCRATCHES OF THE URETHRA.

Additional Manufacturer Narrative

ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.