MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-07 for PHOTON GUIDE ILLUMINATOR 104008 manufactured by Invuity Inc..
[101990554]
Plastic photon guide in invuity high retractor was noted to be "blackened" and slightly melted. Was replaced with new guide. No harm to pt. Narrow flat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075741 |
| MDR Report Key | 7323099 |
| Date Received | 2018-03-07 |
| Date of Report | 2018-03-06 |
| Date of Event | 2018-03-05 |
| Date Added to Maude | 2018-03-08 |
| 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 |
| 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 | PHOTON GUIDE ILLUMINATOR |
| Generic Name | RETRACTOR FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2018-03-07 |
| Catalog Number | 104008 |
| Lot Number | AB17120602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVUITY INC. |
| Manufacturer Address | 444 DE HARO STREET SAN FRANCISCO CA 94107 US 94107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-07 |