MalfunctionFBO
INNER TUBE WITH CERAMIC BEAK
Received Sep 5, 2019 · Event occurred Aug 2, 2019
Report 9610617-2019-00073 · MDR key 8966441
Device
Generic name
Resectoscope Sheath Inner Tube
Manufacturer
Karl Storz Se & Co. KgModel number
27050XACatalog number
27050XA
Product problems
- Break
Patient
48 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE SUBJECT DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE OF THIS TYPE OF BREAKAGE IS MECHANICAL FORCE.
Description of Event or Problem
ALLEGEDLY, DURING A HYSTEROSCOPIC MYOMECTOMY PROCEDURE, THE TIP OF THE RESECTOSCOPE INNER TUBE BROKE INTO MULTIPLE PIECES INTRA-UTERINE. THEY WERE ABLE TO REMOVE ALL PIECES EXCEPT FOR ONE PIECE APPROXIMATELY ONE MILLIMETER IN SIZE, WHICH THEY BELIEVE WAS MOST LIKELY FLUSHED OUT DURING THE PROCEDURE.