FDA Adverse Event
Malfunction
Summary report: N
TRULIGHT
MDR report key: 7276340
·
Received February 16, 2018
Report
- Report Number
- 9681407-2018-00011
- Event Type
- Malfunction
- Date Received
- February 16, 2018
- Date of Event
- January 17, 2018
- Report Date
- January 17, 2018
- Manufacturer
- TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
- Product Code
- FSY
- PMA / PMN Number
- K102758
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A TRUMPF MEDICAL SERVICE TECHNICIAN WAS DISPATCHED TO INSPECT THE LIGHT SYSTEM. THE TECHNICIAN OBSERVED THAT THE LIGHT APPEARED TO HAVE COLLIDED WITH OTHER EQUIPMENT. IT WAS ALSO NOTED THAT THE LENSE COVERS WERE CRACKED. THE LIGHTS WERE REPAIRED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
A CUSTOMER ALLEGED THAT PIECES OF A TRUMPF MEDICAL TRULIGHT DUO SURGICAL LIGHT SYSTEM FELL INTO THE STERILE FIELD. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122341 | TRULIGHT | TRULIGHT DUO | FSY | TRUMPF MEDIZIN SYSTEME GMBH + CO. KG | 1574850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |