MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-12-09 for SPY-PHI HANDHELD IMAGER HH9030 manufactured by Novadaq Technologies.
[169852944]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[169852945]
It was reported that a tumor removal procedure resulted in patient death. Please note, at this time, it cannot be determined which, if any, of the reported devices may have caused or contributed to patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012345110-2019-00011 |
| MDR Report Key | 9437724 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-12-09 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-11-07 |
| Date Mfgr Received | 2019-11-11 |
| Device Manufacturer Date | 2018-08-16 |
| Date Added to Maude | 2019-12-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROOMI BANERJEE DUA |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | NOVADAQ TECHNOLOGIES |
| Manufacturer Street | 8329 EASTLAKE DRIVE, UNIT 101 BURNABY |
| Manufacturer City | BRITISH COLUMBIA V5A 4W2 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | V5A 4W2 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPY-PHI HANDHELD IMAGER |
| Generic Name | CONFOCAL OPTICAL IMAGING |
| Product Code | OWN |
| Date Received | 2019-12-09 |
| Returned To Mfg | 2019-12-10 |
| Catalog Number | HH9030 |
| Lot Number | HH18280587 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVADAQ TECHNOLOGIES |
| Manufacturer Address | 8329 EASTLAKE DRIVE, UNIT 101 BURNABY BRITISH COLUMBIA V5A 4W2 CA V5A 4W2 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-12-09 |