FDA Adverse Event
Malfunction
Summary report: N
MST8 FINAL ASSY JRZ
MDR report key: 1080382
·
Received July 24, 2008
Report
- Report Number
- 3005075853-2005-00379
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 16, 2008
- Report Date
- June 16, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- KNW
- PMA / PMN Number
- K003297
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- RADIOLOGIC TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 7/10/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, THE STERILE PACKAGING WAS FOUND TO BE NOT SEALED. ANOTHER PROBE WAS USED FOR THE CASE. THE MARKER WAS UNABLE TO BE DEPLOYED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE MARKER DEPLOYMENT. THERE WERE NO ADVERSE PT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MST8 FINAL ASSY JRZ | NONE | KNW | ETHICON ENDO-SURGERY, LLC. | NA | E4KX9A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DRIVER| CONTROL MODULE |