inforMED
MalfunctionFSZ

PHOTONSABER F, 12 FR, STANDARD, ROUND

Received Feb 20, 2024 · Event occurred Jan 30, 2024

Report 3015967359-2024-00407 · MDR key 18744465

Device

Generic name

Photonguide Adapt

Catalog number

1911273

Lot number

UNKNOWN

Product problems

  • Detachment of Device or Device Component
  • 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

UPDATE: D9, H3, H6 CORRECTION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

Description of Event or Problem

PER THE CUSTOMER THE DEVICE DISASSEMBLED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

Description of Event or Problem

PER THE CUSTOMER THE DEVICE DISASSEMBLED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.