inforMED
MalfunctionMFJ

MDR event

Received Sep 26, 2018 · Event occurred Aug 31, 2018

Report 1219930-2018-05242 · MDR key 7912378

Device

Model number

020240

Catalog number

020240

Lot number

126-12

Product problems

  • Difficult or Delayed Positioning
  • Difficult or Delayed Positioning

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, DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, WHEN THE FIRST DEVICE WAS USED AT THE ORAL SIDE OF THE COLON, THE NEEDLE WAS DIFFICULT TO GO THROUGH THE TISSUE. NO PATIENT INJURY.