FDA Adverse Event
Malfunction
Summary report: N
GAMMA PROBE COVER
MDR report key: 1532043
·
Received October 15, 2009
Report
- Report Number
- 1532043
- Event Type
- Malfunction
- Date Received
- October 15, 2009
- Date of Event
- September 23, 2009
- Report Date
- October 14, 2009
- Manufacturer
- TECH MEDICAL SERVICES, INC.
- Product Code
- IZD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
A NEW NAVIGATOR WAS BEING TRIALED FOR SENTINEL NODE BIOPSIES ON THIS PATIENT. WE USED THE PROBE COVER THAT WAS GIVEN TO US BY THE VENDOR. THIS COVER IS MUCH THINNER THAN THE PREVIOUS MODEL. AT THE END OF THE CASE, IT WAS DISCOVERED TO HAVE BROKEN OPEN AT ITS TIP WHICH EXPOSED THE PATIENT TO THE UNSTERILE METAL ON THE NEOPROBE IN HER RIGHT AXILLA.
Description of Event or Problem · 1
A NEW NAVIGATOR WAS BEING TRIALED FOR SENTINEL NODE BIOPSIES ON THIS PATIENT. WE USED THE PROBE COVER THAT WAS GIVEN TO US BY THE VENDOR. THIS COVER IS MUCH THINNER THAN THE PREVIOUS MODEL. AT THE END OF THE CASE, IT WAS DISCOVERED TO HAVE BROKEN OPEN AT ITS TIP WHICH EXPOSED THE PATIENT TO THE UNSTERILE METAL ON THE NEOPROBE IN HER RIGHT AXILLA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GAMMA PROBE COVER | GAMMA PROBE COVER | IZD | TECH MEDICAL SERVICES, INC. | * | C1853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |