FDA Adverse Event
Malfunction
Summary report: N
MAMMOTOME CONTROL MODULES
MDR report key: 726356
·
Received June 14, 2006
Report
- Report Number
- 1527736-2006-02714
- Event Type
- Malfunction
- Date Received
- June 14, 2006
- Date of Event
- May 23, 2006
- Report Date
- May 23, 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED UPON THE INQUIRY INFORMATION RECEIVED VISUAL AND FUNCTIONAL EXAMINATION: THE UNIT WAS FOUND TO REQUIRE THE DC MOTOR ADAPTOR TO BE REPLACED. THE DEVICE WAS FUNCTIONALLT TESTED, MET ALL PRODUCT REQUIREMENTS AND RETURNED TO THE CUSTOMER. THE PMA/510(K)# IS K99190.
Description of Event or Problem · 1
THE LOANER HOLSTER WAS EVALUATED FOR PERFORMANCE BEFORE SHIPPING OWERN'S UNIT, AND THE MESSAGE APPEARED ON LCD SCREEN TO INDICATE BREAKDOWN. THE CUSTOMER UNPLUGGED THE LOANER HOLSTER TO REVEAL A BROKEN DC MOTOR ADAPTER IN THE GREEN CABLE PORT OF THEIR SCM12 CONTROL MODULE. NO PT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAMMOTOME CONTROL MODULES | KNW | KNW | ETHICON ENDO SURGERY, INC.(CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | HOLSTER| PROBE |