InjuryFHO
ENDOPATH INSUFFLATION NEEDLES
Received Mar 2, 1999
Report 1527736-1999-01185 · MDR key 212192
Device
Generic name
Needle
Manufacturer
Ethicon Endo-surgery, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Difficult to Insert
Patient
UNKNOWN
- Punctured blood vessels
- Transfusion of blood products
- Needle Stick/Puncture
- Surgical procedure, additional
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE REP THE DEVICE WAS USED IN A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED DURING INSERTION OF EITHER THE PNEUMO NEEDLE OR TROCAR, BOTH THE ILIAC VESSEL AND SMALL BOWEL WAS PUNCTURED. IT IS NOT KNOWN WHICH NEEDLE WAS USED, BUT THE HOSPITAL USUALLY USES PN120. THE DR STATED AFTER THE CASE THE FUNCTIONING OF THE SHIELD WAS TESTED AND WORKED PROPERLY. THE PT WAS OPENED AND TRANSFUSED. THERE WAS A REOPERATION IN THE NEXT DAY OR TWO, SURGEON SAID IT WAS NOT ATTRIBUTABLE TO THE INJURY - POSSIBLE HEMORRHAGE FROM OVARY OR TUBE. THE PT IS NOW OK.
Remedial action
- Other