inforMED
MalfunctionGFD

ACCULAN

Received May 18, 2011 · Event occurred May 12, 2011

Report 2096877 · MDR key 2096877

Device

Generic name

Dermatome

Manufacturer

Aesculap, Inc.

Model number

GA643

Catalog number

GA643

Lot number

*

Product problems

  • Failure to Cut

Patient

18 YR

  • Tissue Damage

Narrative

Description of Event or Problem

A PATIENT WAS BROUGHT TO THE OR (OPERATING ROOM)TO HAVE A SKIN GRAFT PLACED OVER A FASCIOTOMY SITE ON LEFT CALF AREA. WE SET UP THE AESCULAP DERMATOME. THE SURGEON SET THE THICKNESS TO THE DESIRED SETTING. WHEN HE PROCEEDED TO USE THE DERMATOME IT DID NOT TAKE THE SKIN AS A WHOLE. THERE WAS A STRIP OF SKIN THAT DID NOT CUT. SURGEON WAS UNABLE TO USE THE PIECE OF SKIN THAT WAS GRAFTED BECAUSE THERE WAS A HOLE IN IT. THE SURGEON USED A DIFFERENT MANUFACTURER/MODEL OF DERMATOME TO ACQUIRE A SECOND GRAFT THAT WAS USED TO COMPLETE PROCEDURE.======================MANUFACTURER RESPONSE FOR DERMATOME, ACCULAN (PER SITE REPORTER)======================MANUFACTURER PROVIDED RGA NUMBER FOR PRODUCT RETURN EVALUATION.