PRECISOR PULMONARY BIOPSY FORCEP
Received May 16, 2006 · Event occurred Mar 1, 2006
Report 1223688-2006-00012 · MDR key 715769
Device
Generic name
Forcep
Manufacturer
Conmed Endoscopic TechnologiesModel number
NACatalog number
100513
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
- Failure to Align
Patient
UNKNOWN
- Dural Tear
- Hematoma
- 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 VOMITED AFTER EACH FEEDING. AN ENDOSCOPIC PROCEDURE WAS PERFORMED AND FOUND THAT A HEMATOMA HAD 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'S HOSPITAL STAY WAS EXTENDED WHILE THEY RECEIVED IV NUTRITION. THE PT WAS DISCHARGED THREE DAYS AFTER THE PROCEDURE AS THE PT'S MOTHER WAS NURSE AND WAS ABLE TO CONTINUE ADMINISTERING THE IV NUTRITION.