FDA Adverse Event
Injury
Summary report: N
HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE
MDR report key: 280123
·
Received May 31, 2000
Report
- Report Number
- 1527736-2000-02387
- Event Type
- Injury
- Date Received
- May 31, 2000
- Report Date
- May 10, 2000
- Manufacturer
- *
- Product Code
- LFL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A LAPAROSCOPIC LYSIS OF ADHESIONS. IT WAS REPORTED BY THE REP THAT THE LCSC5 WAS BEING USED BY THE SURGEON, TO TAKE DOWN ADHESIONS. THE SURGEON REPORTED TO THE REP THAT LATERAL THERMAL SPREAD FROM THE LCSC5 CAUSED SMALL BOWEL INJURY AND SUBSEQUENT PERFORATION. THE PT WAS REOPERATED/SMALL BOWEL RESECTION FOR 7 DAYS. THE TOTAL HOSP STAY WAS 10 DAYS. THE DEVICE IS NOT BEING RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE | ULTRASONIC-SURGERY DEVICES - ENDOSCOPIC | LFL | * | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |