FDA Adverse Event
Malfunction
Summary report: N
MAMMOMARK2 8 MR BIOSITE INDENT
MDR report key: 1070560
·
Received July 2, 2008
Report
- Report Number
- 3005075853-2008-00253
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- June 9, 2008
- Report Date
- June 9, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- FZP
- PMA / PMN Number
- K003777
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 07/02/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE INCLUDED IN THE PROCEDURE KIT IS BREAKING OFF DURING THE DEPLOYMENT PROCESS. THE PROCEDURE WAS COMPLETED USING ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAMMOMARK2 8 MR BIOSITE INDENT | FZP | ETHICON ENDO-SURGERY, LLC. | NA | E4KF8M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | POWER DRIVER| CONTROL UNIT |