INNER TUBE WITH CERAMIC BEAK
Received Jul 15, 2019 · Event occurred Oct 16, 2018
Report 9610617-2019-00061 · MDR key 8791511
Device
Generic name
Inner Tube With Ceramic Beak
Manufacturer
Karl Storz Se & Co. KgModel number
27050XBCatalog number
27050XB
Product problems
- Material Separation
- Material Separation
Patient
58 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE BROKEN INSTRUMENT WAS NOT RETURNED FOR EVALUATION. DURING OUR INVESTIGATION OF THE PREVIOUS COMPLAINT MENTIONED IN THE EVENT DESCRIPTION OF THIS REPORT, WE LEARNED THAT INNER TUBE WAS 3RD PARTY REPAIRED, AS THE CERAMIC BEAK WAS NOT OF OUR MANUFACTURE. THE MOST LIKELY CAUSE OF THE CERAMIC BEAK BREAKING IS MECHANICAL FORCE.
Description of Event or Problem
DURING OUR INVESTIGATION OF A COMPLAINT REGARDING AN INNER TUBE CERAMIC BEAK THAT BROKE OFF INTO A PATIENT, WE WERE INFORMED BY THE FACILITY THAT, ALLEGEDLY, THEY HAD PREVIOUS CASE DURING WHICH A PIECE OF THE INNER TUBE'S CERAMIC BEAK BROKE OFF INTO THE PATIENT; THE PROCEDURE WAS A RIGHT URETEROSCOPY, RIGHT RETROGRADE PYELOGRAM, LASER LITHOTRIPSY, ATTEMPTED URETERAL STENT INSERTION PROCEDURE. THE HOSPITAL STATED THAT THE SCRUB NURSE NOTICED THE BEAK WAS MISSING A PIECE; THE PATIENT WAS X-RAYED IMMEDIATELY AND THE BROKEN PIECE WAS SEEN IN THE BLADDER AND THE SURGEON RETRIEVED IT DURING THE SAME PROCEDURE. THEY REPORTED THERE WAS NO HARM TO PATIENT.