MalfunctionIZD

NEOPROBE ETHICON

Received Sep 4, 2001 · Event occurred Apr 23, 2001

Report MW1022770 · MDR key 350421

Device

Generic name

Probe

Manufacturer

Ethicon Endosurgery Inc.

Model number

PROBE NPR 14 (1017)

Catalog number

Lot number

Product problems

Component(s), broken
Disconnection

Patient

78 YR

Foreign body, removal of
Surgical procedure, additional

Narrative

Description of Event or Problem

HEAD OF NEOPROBE DISCONNECTED FROM PROBE INSIDE PATIENT'S CHEST CAVITY. IT WAS DETERMINED THAT THE RUBBER COVER BROKE AND THE 14MM TIP FELL OFF THE PROBE INTO THE CHEST CAVITY. THE TIP (COLLIMATOR) WAS RETRIEVED BY MD. FOLLOW UP ACTION: INFORMATION WAS SHARED REGARDING THE USE OF THE NEOPROBE INTRAOPERATIVELY AND THE DRAPING OF THE NEOPROBE. THE COMPANY (ETHICON) WAS CONTACTED REGARDING THE TIP OF THE PROBE FALLING OFF. THE COMPANY REPRESENTATIVE AND SERVICE LEADER ARE WORKING ON STEPS TO PREVENT THIS FROM HAPPENING AGAIN.