STONE CRUSHING FORCEPS, SGL. ACTION JAWS
Received Aug 4, 2025
Report 9610617-2025-01342 · MDR key 22708608
Device
Generic name
Stone Crushing Forceps, Sgl. Action Jaws
Manufacturer
Karl Storz Se & Co. KgModel number
27074BCatalog number
27074B
Lot number
YP06
Product problems
- Break
- Detachment of Device or Device Component
- Break
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
RESULT OF INVESTIGATION: THE DEVICE WAS SENT TO THE MANUFACTURER FOR INSPECTION. DURING THE MANUFACTURER'S TECHNICAL INSPECTION, THE ERROR DESCRIPTION PROVIDED BY THE CUSTOMER, "PIECE BROKEN OFF", COULD BE CONFIRMED. THE ATTACHMENT/CONNECTOR BETWEEN THE DRAWBAR AND THE MOVABLE JAW IS BROKEN. DUE TO THE AGE OF THE INSTRUMENT AND THE PRESUMED NUMBER OF TIMES IT HAS BEEN REPROCESSED, THIS CAN BE ATTRIBUTED TO WEAR AND TEAR OR USER ERROR. THE MATERIAL MAY HAVE BROKEN DUE TO EXCESSIVE FORCE, WHICH HAS ALTERED ITS PROPERTIES THROUGH USE AND CLEANING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Additional Manufacturer Narrative
CORRECTION IN SECTION H11. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO 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
ACCORDING TO THE INFORMATION RECEIVED, AFTER FIRST USE, THE JAWS WERE BROKEN EASILY. ACCORDING TO THE AVAILABLE PICTURE, THE PIN OF THE JOINT AND A PIECE NEAR THE PIN ARE BROKEN OFF. NO PATIENT INVOLVEMENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.