inforMED
MalfunctionGET

ENDO DISSECT* 5MM INSTRUMENT

Received Oct 24, 2016

Report 2647580-2016-00866 · MDR key 6052022

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

176645

Catalog number

176645

Lot number

P6B0587X

Product problems

  • Failure to Align
  • Failure to Align

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

(B)(4). (B)(6).

Description of Event or Problem

ACCORDING TO THE REPORTER THE TIP OF THE DEVICES DOES NOT ALIGN CORRECTLY WHEN USING THEM.