FDA Adverse Event
Malfunction
Summary report: N
BIOPSYS DRIVERS
MDR report key: 725901
·
Received June 8, 2006
Report
- Report Number
- 1527736-2006-02614
- Event Type
- Malfunction
- Date Received
- June 8, 2006
- Date of Event
- May 9, 2006
- Report Date
- June 5, 2006
- Manufacturer
- ETHICON ENDO-SURGERY, INC.(CINCINNATIA)
- Product Code
- KNW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: BASED UPON THE INQUIRY INFORMATION RECEIVED VISUAL AND FUNCTIONAL EXAMINATION: THE UNIT WAS FOUND TO REQUIRE THE POWER CABLE TO BE REPLACED. THE DEVICE WAS FUNCTIONALLY TESTED, MET ALL PRODUCT REQUIREMENTS AND RETURNED TO THE CUSTOMER. 510(K) IS K992813.
Description of Event or Problem · 1
THE CUTTER KNOB WHEN ACTIVATED IS MAKING THE CUT BUT DOES NOT WANT TO STOP. THERE HAVE BEEN NO PT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOPSYS DRIVERS | KNW | KNW | ETHICON ENDO-SURGERY, INC.(CINCINNATIA) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | (1) PROBE, (2) CONTROL MODULE |