NEEDLE HOLDER
Received Mar 7, 2026
Report 9610617-2026-00486 · MDR key 24540427
Device
Generic name
Needle Holder
Manufacturer
Karl Storz Se & Co. KgModel number
26173HACatalog number
26173HA
Lot number
XR01
Product problems
- No Display/Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
CUSTOMER COMPLAINS ABOUT BUILD QUALITY, AS PRODUCT IS DEFECTIVE AFTER ONLY 8 WEEKS: FAULT: A PART HAS BROKEN OFF AT THE MOUTH. NO PATIENT INVOLVEMENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.