FDA Adverse Event Death Summary report: N

ENDOPATH OPTIVIEW TROCAR 5MM NONHANDLED, 75MM

MDR report key: 239881 · Received September 14, 1999

Report

Report Number
1527736-1999-04882
Event Type
Death
Date Received
September 14, 1999
Date of Event
August 25, 1999
Report Date
August 27, 1999
Manufacturer
ETHICON ENDO-SURGERY
Product Code
GCJ
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NJ, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

IT WAS REPORTED BY THE REP THE DEVICES WERE USED DURING A DIAGNOSTIC LAPAROSCOPY. IT WAS REPORTED THE USSC VERESS NEEDLE WAS USED FOLLOWED BY 511SD, THEN 2, 35OS TROCARS WERE INSERTED UNDER DIRECT VISUALIZATION. THE CASE WAS STARTED AND IT WAS REPORTED SURGEON SAW SOME BLEEDING DURING CASE, BUT DID NOT FIND SOURCE. CHECKED TROCAR SITES AND THEY WERE FINE. SURGEON USED LCSK5 TO TAKE DOWN ADHESIONS, NO BLOOD VESSELS. THERE WERE NO DIFFICULTIES OBSERVED WITH THE HARMONIC SCALPEL. ADNEXA ON BOTH SIDES REPORTEDLY HEAVY WITH ADHESIONS. DURING THIS TIME A SECOND SURGEON DAME IN AND STARTED ASSISTING DR LOST PNEUMOPERITONEUM IN THE BELLY, SAW A LOT OF POOLING BLOOD. SUCTIONED OUT. THIS OCCURRED TWO MORE TIMES DURING THE CASE. REP REPORTED DR VERBALIZED CONCERN ABOUT THE BLOOD POOLING, BUT 2ND DR CONTINUED CAUSE. ENDED UP TAKING DOWN ADHESIONS AND CHECKING TUBE PATENCY WITH DYE. THE LEFT TUBE WAS PATENT, THE RIGHT BLOCKED, BUT AFTER MANIPULATION OF THE RIGHT TUBE THE DYE DID FLOW THROUGH. THE CASE WAS COMPLETED AND THE TROCARS WERE REMOVED AND PT CLOSED. REP REPORTED THIS WAS THE FIRST TIME THE HARMONIC SCALPEL WAS USED AT THIS HOSP AND THIS WAS A FIRST TIME USER OF NBO TRACARS. CURRENT EVAL HAS BEEN STOPPED. ANOTHER REP WAS IN THE HOSP THE NEXT DAY AND OVERHEARD THE STAFF SPEAKING OF THIS EVENT. THE PT EXPIRED, BUT NO DETAILS ARE YET AVAILABLE ABOUT THE PT'S CONDITION AND SEQUENCE OF EVENTS ONCE SHE LEFT THE O.R.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ENDOPATH OPTIVIEW TROCAR 5MM NONHANDLED, 75MM TROCARS GCJ ETHICON ENDO-SURGERY NA UNK

Patients

Seq Age Sex Outcome Treatment
1 38 YR Death