FDA Adverse Event
Malfunction
Summary report: N
MAMMOTOME HARDWARE HOLSTER
MDR report key: 1022706
·
Received June 9, 2006
Report
- Report Number
- 1527736-2006-02644
- Event Type
- Malfunction
- Date Received
- June 9, 2006
- Date of Event
- May 16, 2006
- Report Date
- May 16, 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
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: BASED UPON THE INQUIRY INFO REC'D VISUAL AND FUNCTIONAL EXAMINATION: THE UNIT WAS FOUND TO REQUIRE THE COCKING LEVER BE REPLACED. THE DEVICE WAS FUNCTIONALLY TESTED, MET ALL PRODUCT REQUIREMENTS AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE BLACK CABLE HAS SEVERAL TEARS AND RIPS ALONG THE SIDE OF THE CABLE. NO PT CONSEQUENCES REPORTED AND NO INTERRUPTIONS IN THE PROCEDURE.
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 | PROBE| CONTROL MODULE |