FDA Adverse Event
Injury
Summary report: N
REUSABLE SWITCH-BLADE SHAFT, 32CM
MDR report key: 334252
·
Received May 23, 2001
Report
- Report Number
- 1038548-2001-00026
- Event Type
- Injury
- Date Received
- May 23, 2001
- Report Date
- April 27, 2001
- Manufacturer
- GENZYME SURGICAL PRODUCTS CORP.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORTER ALLEGED THAT OVER A PERIOD OF FIVE MONTHS THERE HAVE BEEN THREE OR FOUR CASES OF TISSUE BURNS WHILE USING THE SWITCHBLADE SCISSOR. THE DOCTOR WAS CONTACTED FOR INFORMATION. PER THE PHYSICIAN, THE CASES WERE ALL LAPARASCOPIC DONOR NEPHRECTOMY OPERATIONS. FOR THREE OF THE CASES, AS THE KIDNEY WAS DISSECTED, LITTLE BURNS WERE NOTED AROUND THE COLON DURING THE PROCEDURE. THE DOCTOR STATED THE BURNS WERE REASONABLY SUPERFICIAL AND THE PATIENT WAS NOT INJURED. THE PATIENTS HAVE HEALED AND ARE DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24106 | REUSABLE SWITCH-BLADE SHAFT, 32CM | ELECTROSURGICAL DEVICE | GEI | GENZYME SURGICAL PRODUCTS CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |