FDA Adverse Event
Injury
Summary report: N
HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS
MDR report key: 155687
·
Received March 12, 1998
Report
- Report Number
- 1527736-1998-00700
- Event Type
- Injury
- Date Received
- March 12, 1998
- Date of Event
- February 12, 1998
- Manufacturer
- EES-SMITHFIELD
- Product Code
- KNS
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
IT WAS REPORTED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION WITH THE LCS15, THERE WAS NO HEMOSTASIS ON APPROX THE THIRD OR FOURTH USAGE. THE PT WAS OPENED DUE TO THE DIVIDED VESSEL AND BEING UNABLE TO GAIN CONTROL LAPAROSCOPICALLY. THE PT LOST APPROX 1600CC OF BLOOD. THE SYSTEM WAS STILL SET UP WHEN THE REP ARRIVED AND HE STATED THE GENERATOR AND HAND PIECE APPEARED TO BE WORKING PROPERLY, CE0123-200212, AND THE CORD WAS OKAY. 2/12/1998 THE DEVICE IS NOW IN THE HOSPITAL'S POSSESSION. THE REP WAS TOLD THE LCS WAS REASSEMBLED DURING THE CASE, AND THE ALIGNMENT PIN WAS NOT USED IN THIS ASSEMBLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS | COAGULATING SHEAR | KNS | EES-SMITHFIELD | NA | L48W7C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |