inforMED
MalfunctionEZO

KNIFE, STRAIGHT

Received May 17, 2023 · Event occurred Jun 4, 2018

Report 9610617-2023-00619 · MDR key 16950075

Device

Generic name

Knife, Straight

Model number

27068K

Catalog number

27068K

Lot number

GF01

Product problems

  • Fracture
  • Fracture

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE BLADE SECTION OF THE INSTRUMENT BROKE OFF THE SHAFT SECTION. THE INSTRUMENT WAS ATTACHED TO THE WORKING ELEMENT PART OF THE UROLOGY RESECTOSCOPE. THE BLADE BROKE OFF DURING THE PATIENT PROCEDURE.

Additional Manufacturer Narrative

BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0052 CORRECTIVE ACTION 6. THE BLADE IS LATERAL BENT, COMPLETELY BLUNT AND BROKEN AT THE JUNCTION TO THE RAIL. THE BROKEN SURFACE IS NOT DISCOLOURED, WHICH INDICATES A FRESH BREAK - THE APPEARANCE OF THE BREAK POINTS TOWARDS OVERLOAD. THE IFU CONTAINS WARNINGS TOWARDS THESE DAMAGES - SPECIAL THE LATERAL BENDING HAS A SEPARATE SECTION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).