inforMED
InjuryDWZ

PRECISOR PULMONARY BIOPSY FORCEP

Received May 16, 2006 · Event occurred Mar 1, 2006

Report 1223688-2006-00011 · MDR key 715775

Device

Generic name

Forcep

Model number

NA

Catalog number

100513

Lot number

UNK

Product problems

  • Unknown (for use when the device problem is not known)
  • Failure to Align

Patient

UNKNOWN

  • Hematoma
  • Vomiting
  • Therapy/non-surgical treatment, additional
  • Therapy/non-surgical treatment/delayed/prolonged
  • Treatment with medication(s)
  • Hospitalization required

Narrative

Description of Event or Problem

ONE DAY AFTER OBTAINING A TISSUE SAMPLE FROM THE DUODENUM, THE PT VOMITTED AFTER EACH FEEDING. AN ENDOSCOPIC PROCEDURE WAS PERFORMED AND FOUND THAT A HEMATOMA HAD FORMED IN THE AREA OF THE FIRST SAMPLE SITE. IT APPEARED AS IF THE TISSUE HAD BEEN TORN WHICH MAY HAVE BEEN A RESULT OF THE JAWS NOT BEING SHARP ENOUGH OR ALIGNED CORRECTLY TO CUT THEREBY TEARING THE TISSUE INSTEAD OF CUTTING IT. IT IS UNK HOW MANY SAMPLES WERE TAKEN WITH THE DEVICE. THE PT RECEIVED IV NUTRITION WHILE THE HEMATOMA HEALED AND REMAINS HOSPITALIZED FOR OTHER CANCER RELATED ISSUES.