KARL STORZ
Received Feb 9, 2010 · Event occurred Jan 7, 2010
Report 9610617-2010-00002 · MDR key 1616560
Device
Generic name
Obturator
Manufacturer
Karl Storz Gmbh & Co. KgModel number
11605FOCatalog number
11605FO
Lot number
KH
Product problems
- Tip breakage
Patient
Not reported
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
ALLEGEDLY, DURING A SELECTIVE FETOSCOPY LASER PHOTO COAGULATION PROCEDURE, DOCTOR REMOVED OBTURATOR AND FOUND THAT THE TIP WAS MISSING; THROUGH VISUALIZATION, HE CONFIRMED TIP WAS STILL IN PT. HE COMPLETED PROCEDURE. DOCTOR DECIDED IT WOULD BE SAFER TO LEAVE BROKEN PIECE IN PT AND REMOVE IT DURING DELIVERY.
Additional Manufacturer Narrative
THE SHAFT IS SLIGHTLY BENT IN TWO PLACES AND THE DISTAL TIP (8.5MM IN LENGTH) HAS COME OFF. THE TIP IS LASER WELDED TO THE SHAFT. MANUFACTURER SAID THAT IT IS POSSIBLE THAT WELD WAS MECHANICALLY DAMAGED DURING CLEANING PROCESS CAUSING TIP TO BECOME LOOSE. DEVICE WAS RETURNED TO HOSPITAL AT THEIR REQUEST.