FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS, KNI
MDR report key: 294987
·
Received September 5, 2000
Report
- Report Number
- 1527736-2000-04148
- Event Type
- Malfunction
- Date Received
- September 5, 2000
- Date of Event
- August 2, 2000
- Report Date
- August 8, 2000
- Manufacturer
- ETHICON ENDO-SURGERY - ALB
- Product Code
- LFL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN. IT WAS REPORTED BY THE AFFILIATE THAT THE LCSK5, USED WITH A HARMONIC SCALPEL, WHEN THE UNMOBILE PART OF THE SCISSORS FELL INTO THE PT. THE PART WAS TAKEN OUT WITH NO FURTHER CONSEQUENCE TO THE PT. THE PROCEDURE WAS CONTINUED WITH A CS150.
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 | Other |