RESECTOSCOPE SHAFT, 27 CHARR
Received Nov 24, 2022 · Event occurred Nov 2, 2022
Report 9610617-2022-00313 · MDR key 15860875
Device
Generic name
Resectoscope Shaft, 27 Charr
Manufacturer
Karl Storz Se & Co. KgModel number
27241AOCatalog number
27241AO
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE.
Description of Event or Problem
THE REPORTED EVENT OCCURRED IN GERMANY. DURING A CASE, THE CERAMIC TIP BROKE OFF INSIDE THE PATIENT. THE FRAGMENT COULD BE RETRIEVED. THE CASE COULD BE COMPLETED WITH ANOTHER INSTRUMENT. NO INJURY TO A PATIENT, USER, OR THIRD WAS REPORTED. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).
Additional Manufacturer Narrative
UPON EVALUATION, THE BREAKAGE COULD BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE IS THAT AFTER 12 YEARS MICRO CRACKS HAVE FORMED WHICH HAVE WEAKENED THE BEAK, AND AFTER THIS TIME IT HAS BROKEN DURING USE DUE TO THE RESULTING FORCES. IN THE IFU IT IS POINTED OUT THAT THE CERAMIC BEAK MUST BE CHECKED FOR DAMAGE BEFORE THE OPERATION AND REPLACED IF NECESSARY. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).