inforMED
MalfunctionEZO

KNIFE, STRAIGHT

Received May 17, 2023

Report 9610617-2023-00624 · MDR key 16950069

Device

Generic name

Knife, Straight

Model number

27069K

Catalog number

27069K

Lot number

WS01

Product problems

  • Loose or Intermittent Connection
  • Loose or Intermittent Connection

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Additional Manufacturer Narrative

BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0052 CORRECTIVE ACTION 6. AS THE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION WAS RECEIVED THE CASE WILL BE CLOSED WITHOUT ANY PHYSICAL INVESTIGATION. NO INDICATIONS FOR A SYSTEMATIC ISSUE. IF FURTHER INFORMATION OR THE PRODUCT WILL BECOME AVAILABLE, THE CASE WILL BE REOPENED AND RE-EVALUATED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B(4).

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS EVENT WITH A KNIFE, STRAIGHT. ACCORDING TO THE INFORMATION RECEIVED, AT THE TIME OF USE OF THE ITEM 27069K, CUSTOMER NOTICED THAT THE KNIFE HAD A LOOSE END, MAKING IT IMPOSSIBLE TO USE. ADDITIONAL INFORMATION IS NOT AVAILABLE.