D
Patient 1
IT WAS REPORTED VIA USER FACILITY MEDWATCH: "A PLASTIC PIECE FROM THE LIGHTED ILLUMINATION (WAVEGUIDE) RETRACTOR BROKE OFF DURING SURGERY."
MAUDE MDR 4922547
- MDR report key
- 4922547
- Report number
- 3011394215-2015-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-06-08
- Date received
- 2015-07-13
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JOHN KANG
- Address
- 444 DE HARO ST SAN FRANCISCO CA 94107 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EIGR WAVEGUIDE | RETRACTOR, FIBEROPTIC | INVUITY INC. | FDG | 104015 | NP | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-07-13 | 0 |
Event Narratives#
N
Patient 1
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.