MalfunctionIWF

*

Received Oct 15, 1998 · Event occurred Aug 24, 1998

Report MW1014739 · MDR key 192013

Device

Generic name

20cm Trochar Patient Needle

Manufacturer

Nucletron Oldelft Corp.

Model number

083.924

Catalog number

Lot number

Product problems

Break
Device, or device fragments remain in patient

Patient

54 YR

Nonresorbable materials, unretrieved in body

Narrative

Description of Event or Problem

PT IN FOR RADIATION ONCOLOGY PROCEDURE. TEMPLATE WAS IMPLANTED FOR INSTILLATION OF DUMMIES. DURING PROCEDURE A PORTION OF THE NEEDLE BROKE OFF AND BECAME LODGED IN THE PT'S CERVIX. PORTION OF INSTRUMENT RETAINED AND SENT TO MFR AT THEIR REQUEST FOR EVAL.