MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-07-13 for EIGR WAVEGUIDE 104015 manufactured by Invuity Inc..
[6436364]
It was reported via user facility medwatch: "a plastic piece from the lighted illumination (waveguide) retractor broke off during surgery. "
Patient Sequence No: 1, Text Type: D, B5
[14379149]
The product was not returned to the manufacturer and no lot number was provided. Batch record review was not able to be performed since no lot number was provided. No further investigation can be performed. There was no patient injury involved as reported by the user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011394215-2015-00001 |
| MDR Report Key | 4922547 |
| Report Source | 05,06 |
| Date Received | 2015-07-13 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-06-08 |
| Date Mfgr Received | 2015-06-12 |
| Date Added to Maude | 2015-08-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN KANG |
| Manufacturer Street | 444 DE HARO ST |
| Manufacturer City | SAN FRANCISCO CA 94107 |
| Manufacturer Country | US |
| Manufacturer Postal | 94107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EIGR WAVEGUIDE |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2015-07-13 |
| Catalog Number | 104015 |
| Lot Number | NP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVUITY INC. |
| Manufacturer Address | SAN FRANCISCO CA 94107 US 94107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-13 |