inforMED
MalfunctionGET

ENDO GRASP

Received Oct 25, 2017 · Event occurred Sep 29, 2017

Report 2647580-2017-07348 · MDR key 6976253

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

174233

Catalog number

174233

Lot number

P6K0465X

Product problems

  • Break
  • Product Quality Problem
  • Break
  • Product Quality Problem

Patient

Not reported

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

Narrative

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER: OCCURRED DURING A SINGLE INCISION LAPAROSCOPIC CHOLECYSTECTOMY (SILS) PROCEDURE. THE FRONT PLASTIC PART OF THE GRASPING DEVICE WAS DAMAGED WHEN IT CAME OUT OF THE BOX. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, IT WAS REPLACED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.