MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-06 for TRUMPF MEDICAL TRULIGHT 5520 1574850 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[66925681]
Per tim sharp, biomed, the handle was not on the laser handle correctly. He reinstalled the handle cover properly. The trumpf service technician rechecked the handle cover and it is working as designed.
Patient Sequence No: 1, Text Type: N, H10
[66925682]
The surgical light sterilized laser handle cover fell off during a case and landed in the sterile field. There was no harm to patient as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2017-00006 |
| MDR Report Key | 6305444 |
| Date Received | 2017-02-06 |
| Date of Report | 2017-01-17 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-01-17 |
| Device Manufacturer Date | 2011-12-13 |
| Date Added to Maude | 2017-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEFFEN ULBRICH |
| Manufacturer Street | CARL-ZEISS STRASSE 7-9 |
| Manufacturer City | SAALFELD, 07318 |
| Manufacturer Country | GM |
| Manufacturer Postal | 07318 |
| Manufacturer Phone | 6715864140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRUMPF MEDICAL TRULIGHT |
| Generic Name | TRULIGHT 5520 DUO (ALC+) |
| Product Code | FQP |
| Date Received | 2017-02-06 |
| Model Number | 5520 |
| Catalog Number | 1574850 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRUMPF MEDIZIN SYSTEME GMBH + CO. KG |
| Manufacturer Address | CARL-ZEISS STRASSE 7-9 SAALFELD, 07318 GM 07318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-06 |