inforMED
MalfunctionPZP

HYDROS HANDPIECE

Received Jul 21, 2026 · Event occurred Jun 18, 2026

Report 25889407 · MDR key 25889407

Device

Generic name

Fluid Jet Removal System

Model number

HH1000

Lot number

26C00807

Patient

74 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE PRODUCT FROM HYDROS WITH REF# OF HH1000 LOT# 26C00807 WAS NOT FUNCTIONING PROPERLY . THE HANDPIECE WAS UNABLE TO PERFORM AS INTENDED AND THE DEFECTIVE HANDPIECE WAS REMOVED FROM THE STERILE FIELD AND RETAINED FOR EVALUATION. DISPOSABLE HANDPIECE MALFUNCTIONED. DEFECTIVE HANDPIECE GIVEN TO RISK FOR EVALUATION.