FDA Adverse Event
Malfunction
Summary report: N
MST8 FINAL ASSY JRZ
MDR report key: 862986
·
Received June 8, 2007
Report
- Report Number
- 1527736-2007-04026
- Event Type
- Malfunction
- Date Received
- June 8, 2007
- Date of Event
- May 22, 2007
- Report Date
- May 23, 2007
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- KNW
- PMA / PMN Number
- K003297
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BREAST BIOPSY, METAL SHAVINGS WERE NOTICED IN A SAMPLE SPECIMEN. THE METAL SHAVINGS WERE LEFT WITHIN THE BIOPSY SITE. THE BREAST BIOPSY WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MST8 FINAL ASSY JRZ | KNW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | HOLSTER| CONTROL MODULE |