FDA Adverse Event
Injury
Summary report: N
HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE
MDR report key: 275977
·
Received May 1, 2000
Report
- Report Number
- 1527736-2000-01730
- Event Type
- Injury
- Date Received
- May 1, 2000
- Date of Event
- March 23, 2000
- Report Date
- April 3, 2000
- Manufacturer
- *
- Product Code
- LFL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE REP THAT THE SURGEON WAS USING A NEW HS CURVED SHEAR. THE SURGEON GOT SOME BLEEDING ON A POSTERIOR SHORT GASTRIC AND THE SURGEON CONTROLLED IT WITH THE HS IN WHICH THE SURGEON IS EXTEMELY PROFICIENT. THE SURGEON STATED THE BLEEDING WAS CONTROLLED AND SURGEON NOTED NO ADD'L BLEEDING BEFORE CLOSING. IN THREE TO FOUR HOURS POST OPERATIVE, PT HAD TO BE REOPERATED ON AFTER LOSING OVER THREE UNITS OF BLOOD. THERE WAS EXTENDED OR AND HOSP STAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE | ULTRASONIC-SURGERY DEVICES-ENDOSC | LFL | * | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |