MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-08 for SAVI SCOUT REFLECTOR MARKER manufactured by Cianna Medical.
[85646987]
Pt with abnormal breast imaging, no palpable lump. Breast biopsy with use of savi scout equipment. Savi reflector marker implanted one week prior to surgery. Prior to incision, a pre-test identified the location of the reflector marker. After incision, the reflector marker was unable to be detected/located with the hand-piece. Unable to locate reflector marker with hand detector, a c-arm with fluoroscopy was employed and successfully located marker. Breast biopsy performed. Post removal of specimen the savi reflector marker was located within the specimen. No harm came to pt. Mfr picked up reflector marker from pathology and returned to their corporate office. Please contact them regarding identification number (s) for the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072045 |
| MDR Report Key | 6851637 |
| Date Received | 2017-09-08 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-08-24 |
| Date Added to Maude | 2017-09-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SAVI SCOUT REFLECTOR MARKER |
| Generic Name | SAVI SCOUT REFLECTOR MARKER |
| Product Code | PDW |
| Date Received | 2017-09-08 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIANNA MEDICAL |
| Manufacturer Address | 6 JOURNEY, STE 25 ALISO VIEJO CA 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-08 |