MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-29 for EIGER WAVEGUIDE 104015 manufactured by Invuity, Inc..
[37072819]
Patient Sequence No: 1, Text Type: N, H10
[37072820]
During breast surgery, the resident noticed the lighted breast retractor that had been working prior was not working properly. Upon further inspection, it was observed that a piece of the waveguide had broken off. The broken piece had fallen into the patient, but was removed. There was no harm to patient and this is a near miss with potential for harm if staff had not found broken plastic piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5398189 |
| MDR Report Key | 5398189 |
| Date Received | 2016-01-29 |
| Date of Report | 2016-01-22 |
| Date of Event | 2016-01-15 |
| Report Date | 2016-01-22 |
| Date Reported to FDA | 2016-01-22 |
| Date Reported to Mfgr | 2016-01-22 |
| Date Added to Maude | 2016-01-29 |
| 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 | 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 | 3 |
| Brand Name | EIGER WAVEGUIDE |
| Generic Name | RETRACTOR, FIBEROOPTIC |
| Product Code | FDG |
| Date Received | 2016-01-29 |
| Catalog Number | 104015 |
| Lot Number | AB15102402 |
| Device Expiration Date | 2017-09-01 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-01-29 |