inforMED
MalfunctionGDM

PUNCTURE NEEDLE ASPIRATOR

Received Apr 23, 2020 · Event occurred Apr 5, 2020

Report 9990387 · MDR key 9990387

Device

Generic name

Needle, Aspiration And Injection, Reusable

Model number

90-5052L

Catalog number

90-5052L

Product problems

  • Break

Patient

8760 DA

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE M.D. USED A LAPAROSCOPIC ASPIRATION NEEDLE. WHILE USING THIS INSTRUMENT, THE NEEDLE TIP BROKE OFF IN THE PATIENT'S ABDOMEN. THE NEEDLE TIP WAS RETRIEVED BY M.D. WITHOUT HARM TO PATIENT. AN INSTRUMENT REPAIR TAG WAS ATTACHED TO INSTRUMENT.