FDA Adverse Event
Injury
Summary report: N
HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS, KNI
MDR report key: 273193
·
Received April 10, 2000
Report
- Report Number
- 1527736-2000-01401
- Event Type
- Injury
- Date Received
- April 10, 2000
- Date of Event
- March 9, 2000
- Report Date
- March 9, 2000
- Manufacturer
- ETHICON ENDO-SURGERY - ALB
- Product Code
- LFL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (1) DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE LCSK5, USED WITH A H2TUV, CUT WITHOUT HEMOSTASIS. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. 3/31/2000 PT LOST 1.5 LITER OF BLOOD AND IT WAS NECESSARY TO PERFORM A SPLENECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS, KNI | ULTRASONIC-SURGERY DEVICES - ENDOSC | LFL | ETHICON ENDO-SURGERY - ALB | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |