inforMED
MalfunctionGEI

TELEFLEX MINIGRIP

Received Apr 25, 2018

Report 3002770040-2018-12348 · MDR key 7457955

Device

Generic name

Minigrip Clutch Grasper

Model number

PGCC300

Catalog number

PGCC300

Lot number

GML-00112

Product problems

  • Use of Device Problem
  • Device Handling Problem
  • Use of Device 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

Additional Manufacturer Narrative

THE INITIAL SUBMISSION WAS ERRONEOUSLY SUBMITTED AS A 5 DAY REPORT AND WE WAS NOT REQUIRED TO INITIATE ACTION TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM.

Description of Event or Problem

THE SURGEON IS GIVEN THE MINIGRIP, PRACTICED HOW TO ARM IT AND THE GRASPING SENSATION. SHE ARMS THE NEEDLE AND INSERTS THE DEVICE, ONCE IN THE ABDOMEN THE ARMING BUTTON WAS RELEASED. AS THE JAWS OPENED THEY NOTICED THAT THERE WAS A PIECE MISSING. THE SURGEON IS SURE THAT IT DIDN'T FALL IN THE ABDOMEN BUT BROKE DURING THE ARMING OF THE TIP. THEY TOOK OUT THE MINIGRIP AND DID THE PROCEDURE WITH A TROCAR AND 5MM GRASPER. NO ADDITIONAL SURGERY WAS NECESSARY, JUST AN ABDOMEN X-RAY IN WHICH IT WAS CONFIRMED THAT THE MISSING PIECE WAS NOT IN THE PATIENT. THE PATIENT IS FINE AND LEFT THE HOSPITAL THE DAY AFTER THE SURGERY AS IN ROUTINE.

Description of Event or Problem

THE SURGEON IS GIVEN THE MINIGRIP, PRACTICED HOW TO ARM IT AND THE GRASPING SENSATION. SHE ARMS THE NEEDLE AND INSERTS THE DEVICE, ONCE IN THE ABDOMEN THE ARMING BUTTON WAS RELEASED. AS THE JAWS OPENED THEY NOTICED THAT THERE WAS A PIECE MISSING. THE SURGEON IS SURE THAT IT DIDN'T FALL IN THE ABDOMEN BUT BROKE DURING THE ARMING OF THE TIP. THEY TOOK OUT THE MINIGRIP AND DID THE PROCEDURE WITH A TROCAR AND 5MM GRASPER. NO ADDITIONAL SURGERY WAS NECESSARY, JUST AN ABDOMEN X-RAY IN WHICH IT WAS CONFIRMED THAT THE MISSING PIECE WAS NOT IN THE PATIENT. THE PATIENT IS FINE AND LEFT THE HOSPITAL THE DAY AFTER THE SURGERY AS IN ROUTINE.

Additional Manufacturer Narrative

THE INITIAL SUBMISSION WAS ERRONEOUSLY SUBMITTED AS A 5 DAY REPORT AND WE WAS NOT REQUIRED TO INITIATE ACTION TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM.