ARTICULATED STAND, L-SHAPED, LONG
Received Jan 27, 2025
Report 9610617-2025-00059 · MDR key 21242214
Device
Generic name
Articulated Stand
Manufacturer
Karl Storz Se & Co. KgModel number
28272HCCatalog number
28272HC
Lot number
UM01
Product problems
- Break
- Break
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE 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. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Additional Manufacturer Narrative
RESULT OF INVESTIGATION: DURING INSPECTION OF THE RETURNED PRODUCT TWO CLAMPING JAWS WERE FOUND BROKEN OFF INSIDE. THIS IS LIKELY TO BE DUE TO USER ERROR. THE CLAMPING JAWS INSIDE CAN BREAK IF THE PIN IS NOT FULLY INSERTED INTO THE COUNTERPART (AS DESCRIBED IN THE IFU). THE ENDS OF THE CLAMPING JAWS REST ON THE LARGER DIAMETER OF THE PIN (THEY SHOULD FIT INTO THE AREA WITH THE SMALLER DIAMETER). TURNING/TIGHTENING THE CLAMPING JAWS THUS EXERTS INCREASED FORCE ON THE JAWS, CAUSING THEM TO BREAK. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT EQUIPMENT BROKE THE SECOND TIME IT WAS USED. THE BROKEN PIECES ALMOST FELL INSIDE THE PATIENT DURING THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.