FDA Adverse Event
Injury
Summary report: N
HARMONIC SCALP HND PIECE INTL
MDR report key: 483155
·
Received September 11, 2003
Report
- Report Number
- 1527736-2003-01743
- Event Type
- Injury
- Date Received
- September 11, 2003
- Report Date
- August 20, 2003
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- LFL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE AFFILIATE THAT THE H3TUV WAS USED DURING A LAPAROSCOPIC RADICAL OPERATION OF CARCINOMA OF THE RECTUM. THE BLADE DID NOT WORK DURING THE OPERATION. THE BLADE WAS CHANGED AND IT STILL DID NOT WORK. THE ABDOMINAL CAVITY WAS OPENED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC SCALP HND PIECE INTL | ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECES | LFL | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other| R |