inforMED
MalfunctionGET

ENDO DISSECT* 5MM INSTRUMENT

Received Feb 6, 2017

Report 2647580-2017-00125 · MDR key 6303522

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

176645

Catalog number

176645

Lot number

P6E0109X

Product problems

  • Failure to Align
  • Failure to Align

Patient

Not reported

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

(B)(4).

Additional Manufacturer Narrative

(B)(4). ADDITIONAL ATTEMPTS TO OBTAIN INFORMATION AND THE DEVICE HAVE BEEN MADE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH NEW DETAILS IF THEY BECOME AVAILABLE.

Description of Event or Problem

ACCORDING TO THE REPORTER, THE JAWS OF THE LAPAROSCOPIC INSTRUMENT WERE NOT TANGENT WITH EACH OTHER PROPERLY WHEN THEY ARE IN CLOSED POSITION.