INNER TUBE WITH CERAMIC BEAK
Received Jun 22, 2018 · Event occurred May 31, 2018
Report 9610617-2018-00042 · MDR key 7631898
Device
Generic name
Resectoscope Sheath Inner Tube
Manufacturer
Karl Storz Se & Co. KgModel number
27050XACatalog number
27050XA
Lot number
TU10
Product problems
- Component Falling
- Crack
- Material Separation
- Material Separation
Patient
Not reported
- 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 DEVICE IS APPROXIMATELY 3 YEARS OLD; THE MOST LIKELY CAUSE OF THIS TYPE OF BREAKAGE IS MECHANICAL FORCE.
Description of Event or Problem
ALLEGEDLY, DURING AN INTRA-UTERINE FIBROID RESECTION PROCEDURE, THE TIP OF INNER TUBE CRACKED AND PIECES BROKE OFF INTO THE PATIENT. DOCTOR WAS ABLE TO RETRIEVE THE PIECES AND CONFIRMED THERE WAS NO PATIENT IMPACT.
Additional Manufacturer Narrative
SUPPLEMENTAL REPORT FILED TO CORRECT THE EVENT DATE FROM (B)(6) 2018 TO (B)(6) 2018.
Additional Manufacturer Narrative
WE EVALUATED THE RETURNED DEVICE AND FOUND THE CERAMIC BEAK IS BROKEN OFF FROM THE DISTAL END OF INNER TUBE AND THERE ARE WHAT APPEARS TO BE TOOL MARKS ON THE DISTAL END OF THE SHAFT. DAMAGE IS MOST LIKELY DUE TO THE CERAMIC BEAK MAKING CONTACT WITH A HARD SURFACE CAUSING AN INTERNAL CRACK AND RESULTING IN BREAKAGE; WE CANNOT CONFIRM.