inforMED
MalfunctionGET

ENDO GRASP

Received Aug 12, 2020 · Event occurred Jul 21, 2020

Report 2647580-2020-02544 · MDR key 10395151

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

174233

Catalog number

174233

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact 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, ON A LAPAROSCOPIC HIATAL HERNIA REPAIR, WHEN THE SURGEON WAS PREPARING TO MANEUVER THE DEVICE BEHIND THE ESOPHAGUS, THE ROTATION AND ARTICULATION KNOBS WERE USED THEN A PART OF THE PLASTIC HOUSING CAME OFF INSIDE THE PATIENT. THE PLASTIC WAS RETRIEVED WITH GRASPERS WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.