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MalfunctionLFF

ULTRACISION HARMONIC SCALPEL HAND PIECE

Received Feb 15, 2007 · Event occurred Jan 31, 2007

Report 1527736-2007-00796 · MDR key 836291

Device

Generic name

Lfl

Model number

NA

Catalog number

HP054

Lot number

*

Product problems

  • Device Displays Incorrect Message

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING A LOWER ANTERIOR RESECTION, THE INSTRUMENT DISPLAYED AN ERROR 4. THE CASE WAS COMPLETED WITH CLIPS AND CLAMPS. NO PATIENT CONSEQENCE.

Additional Manufacturer Narrative

INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.