FDA Adverse Event
Injury
Summary report: N
LENSAR LASER SYSTEM-FS 3D
MDR report key: 5494618
·
Received March 11, 2016
Report
- Report Number
- 3009026057-2016-00008
- Event Type
- Injury
- Date Received
- March 11, 2016
- Date of Event
- February 11, 2016
- Report Date
- March 17, 2015
- Manufacturer
- LENSAR, LLC
- Product Code
- OOE
- PMA / PMN Number
- K120214
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803. 56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 1
SERVICE CALL (B)(4) WAS OPENED TO INVESTIGATE THE REPORTED EVENT. THE USERS ARE TRAINED DURING THE INITIAL CLINICAL TRAINING ABOUT THE USE OF THE DIFFERENT WINDOWS. THERE WERE NO PATIENT INJURIES REPORTED BY THE CLINICAL SITE. QB-00027 WAS ISSUED AND WILL BE SENT TO ALL USER REVIEWING THE PROPER USE OF CALIBRATION WINDOW AND PID WINDOWS.
Description of Event or Problem · 1
TWO NON STERILE CALIBRATION WINDOWS WERE USED BY THE USER AS A REPLACEMENT TO PERFORM SURGICAL PROCEDURES.
Description of Event or Problem · 1
TWO NON STERILE CALIBRATION WINDOWS WERE USED BY THE USER AS A REPLACEMENT TO PERFORM SURGICAL PROCEDURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 150674 | LENSAR LASER SYSTEM-FS 3D | LENSAR LASER SYSTEM-FS 3D | OOE | LENSAR, LLC | 70-00024-001 | 49802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |