inforMED
MalfunctionGDM

ASPIRATING NEEDLE

Received Feb 3, 1999 · Event occurred Dec 10, 1998

Report 2515651-1999-00001 · MDR key 208881

Device

Generic name

Esophageal

Model number

*

Catalog number

50-7453

Lot number

*

Product problems

  • Needle, separation
  • Device, or device fragments remain in patient
  • Tip breakage

Patient

75 YR

  • Nonresorbable materials, unretrieved in body
  • Therapy/non-surgical treatment, additional
  • Surgical procedure, additional

Narrative

Description of Event or Problem

PT UNDERWENT MEDIASTINSCOPY IN THE OR. FOLLOWING THE PROCEDURE, WHILE SURGICAL INSTRUMENTS WERE BEING DECONTAMINATED, IT WAS NOTED THAT NEEDLE WAS MISSING FROM THE END OF NEEDLE TIP ASPIRATOR. CHEST X-RAY REVEALED APPROX 1 CM LONG, 1 MM THICK NEEDLE TO THE RIGHT SIDE OF MEDIASTINUM. PT WAS RETUREND TO SURGERY FOR UNSUCCESSFUL ATTEMPT TO RETRIEVE NEEDLE.