MalfunctionLFL

STRYKER / HARMONIC FOCUS SHEARS

Received May 1, 2025

Report MW5169686 · MDR key 21942062

Device

Generic name

Instrument, Ultrasonic Surgical

Manufacturer

Stryker Puerto Rico, Llc.

Catalog number

HAR9F

Lot number

16269841

Product problems

Defective Device
Therapeutic or Diagnostic Output Failure

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

THE STRYKER HARMONIC FOCUS SHEAR HAND PIECE WAS NOT WORKING; CIRCULATOR OPENED A NEW STRYKER HARMONIC FOCUS SHEAR HAND PIECE WAS ALSO NOT WORKING. REF REPORT: MW5169685.