FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 3101368
·
Received May 3, 2013
Report
- Report Number
- 2134070-2013-00102
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 12, 2013
- Manufacturer
- STERILMED, INC.
- Product Code
- NLQ
- PMA / PMN Number
- K111794
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF THE DEVICE IS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A THYRTOIDECTOMY WHEN USING THE DEVICE, THE WHITE "CERAMIC" TIPS WERE FLAKING OFF THE INSTRUMENT INTO THE PATINET. THE PIECES WERE EASILY AND SUCCESSFULLY RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195519 | NA | NLQ | STERILMED, INC. | ETHFCS9 | 1388260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |