MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-09 for TRULIGHT 5000/3000 DUO 4038210 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[123358596]
The service technician replaced the spring arm and the light is functioning as designed. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[123358597]
Between two surgical cases, a spring arm with a trulight 5510 light head detached from the central axis and fell. No patient or caregiver injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2018-00058 |
| MDR Report Key | 7947958 |
| Date Received | 2018-10-09 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-09-10 |
| Date Mfgr Received | 2018-09-10 |
| Device Manufacturer Date | 2013-10-29 |
| Date Added to Maude | 2018-10-09 |
| 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 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRULIGHT 5000/3000 DUO |
| Generic Name | SURGICAL LIGHT |
| Product Code | FQP |
| Date Received | 2018-10-09 |
| Model Number | 4038210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-10-09 |