FDA Adverse Event
Injury
Summary report: N
INVUITY, INC.
MDR report key: 6614502
·
Received June 6, 2017
Report
- Report Number
- 3011394215-2017-00003
- Event Type
- Injury
- Date Received
- June 6, 2017
- Date of Event
- May 16, 2017
- Report Date
- May 17, 2017
- Manufacturer
- INVUITY, INC
- Product Code
- GEI
- UDI-DI
- 00816728020158
- PMA / PMN Number
- K162053
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING A LUMPECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE TELESCOPING WAVEGUIDE FELT HOT. THE PHYSICIAN EXAMINED THE INCISION AREA AND NOTICED A BURN NEAR THE PERI-AREOLA REGION THAT REQUIRED A SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 394844 | INVUITY, INC. | PHOTONBLADE | GEI | INVUITY, INC | PB1 | 17040307 | 00816728020158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |