MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-10-15 for GAMMA PROBE COVER * PS- 6000 manufactured by Tech Medical Services, Inc..
[1246331]
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.
Patient Sequence No: 1, Text Type: D, B5
[1327471]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1532043 |
| MDR Report Key | 1532043 |
| Date Received | 2009-10-15 |
| Date of Report | 2009-10-14 |
| Date of Event | 2009-09-23 |
| Report Date | 2009-10-14 |
| Date Reported to FDA | 2009-10-15 |
| Date Added to Maude | 2009-11-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAMMA PROBE COVER |
| Generic Name | GAMMA PROBE COVER |
| Product Code | IZD |
| Date Received | 2009-10-15 |
| Returned To Mfg | 2009-10-08 |
| Model Number | * |
| Catalog Number | PS- 6000 |
| Lot Number | C1853 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECH MEDICAL SERVICES, INC. |
| Manufacturer Address | 1540 N. COMMERCIAL RD. SUITE 2 NIXA MO 65714 US 65714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-15 |