FDA Adverse Event
Malfunction
Summary report: N
MAMMOTOME HARDWARE HOLSTER
MDR report key: 725915
·
Received June 8, 2006
Report
- Report Number
- 1527736-2006-02615
- Event Type
- Malfunction
- Date Received
- June 8, 2006
- Date of Event
- May 5, 2006
- Report Date
- May 31, 2006
- Manufacturer
- ETHICON ENDO-SURGERY, INC.(CINCINNATI)
- Product Code
- KNW
- PMA / PMN Number
- K99190
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: BASED UPON THE INQUIRY INFORMATION RECEIVED VISUAL AND FUCTIONAL EXAMINATION: THE UNIT WAS FOUND TO REQUIRE THE PCB BOARD TO BE CALIBRATED. THE DEVICE WAS FUNCTIONALLY TESTED, MET ALL PRODUCT REQUIREMENTS AND RETURNED TO THE CUSTOMER. 510(K) IS K99190.
Description of Event or Problem · 1
DURING INITIALIZATION AT START OF CASE, THE CUTTER WOULD NOT ADVANCE. THE SECOND HOLSTER WAS USED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAMMOTOME HARDWARE HOLSTER | KNW | KNW | ETHICON ENDO-SURGERY, INC.(CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | (1) PROBE| (2) CONTROL MODULE |