inforMED
MalfunctionGEI

PGAC300 MINIGRIP ALLIGATOR GRASPER

Received May 21, 2018 · Event occurred Apr 18, 2018

Report 3002770040-2018-12350 · MDR key 7530279

Device

Generic name

Alligator Grasper

Catalog number

PGAC300

Lot number

GML-00161

Product problems

  • Device Handling Problem
  • Device Handling Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • Missing Value Reason
  • No Known Impact Or Consequence To Patient
  • Missing Value Reason

Narrative

Description of Event or Problem

SURGEON WAS USING IN A CASE THIS MORNING. HE MOVED THE RATCHET KNOB UP TO THE "ON" POSITION TO LOCK ONTO A SPECIMEN. WHEN HE WANTED TO REPOSITION HIS GRASP, HE MOVED THE RATCHET KNOB INTO THE "OFF" POSITION AND THEN TRIED TO OPEN THE JAWS OF THE APPLIER BY MOVING THE BLACK HANDLE, BUT THE JAWS DID NOT RELEASE. I TOLD HIM TO SQUEEZE THE HANDLE BACK A LITTLE BIT THEN ALLOWS THE HANDLE TO KIND OF UNHINGE AND THEN IT WILL SPRING OPEN. HE PULLED THE HANDLE BACK A COUPLE TIMES, BUT THE JAWS WOULD NOT OPEN. HE PULLED THE HANDLE FORWARD AND LUCKILY THE JAWS OPENED, BUT IT MADE A LOUD POPPING NOISE AND THE HANDLE DISENGAGED FROM CONTROLLING THE JAWS. HE PULLED THE DEVICE OUT OF THE PATIENT'S ABDOMEN AND OPENED AND CLOSED THE HANDLE A COUPLE TIMES. THE JAWS DID NOT OPEN AND CLOSE AS HE WAS DOING THIS. THERE IS A RATTLING NOISE COMING FROM INSIDE OF THE BODY OF THE HANDLE INDICATING THAT SOMETHING INTERNALLY BROKE.