MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-19 for TRULIGHT 1574851 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[75727918]
It is known that an improper installation, maintenance or a collision can lead to the spring arm cover falling off. The device was evaluated and repaired by a trumpf service technician. The trumpf technician was informed that a third party biomed was aware of the broken elbow cover. No preventative maintenance records were found for this device.
Patient Sequence No: 1, Text Type: N, H10
[75727919]
The elbow cover on an ondal spring arm, attached to the trumpf medical surgical light came off during a surgery and fell, landing in operative field. No patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2017-00016 |
| MDR Report Key | 6579721 |
| Date Received | 2017-05-19 |
| Date of Report | 2017-04-26 |
| Date of Event | 2017-04-26 |
| Date Mfgr Received | 2017-04-26 |
| Date Added to Maude | 2017-05-19 |
| 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, SAALE 07318 |
| Manufacturer Country | GM |
| Manufacturer Postal | 07318 |
| Manufacturer Phone | 6715864140 |
| Manufacturer G1 | TRUMPF MEDIZIN SYSTEME GMBH + CO. KG |
| Manufacturer Street | CARL-ZEISS STRASSE 7-9 |
| Manufacturer City | 07318 SAALFELD, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRULIGHT |
| Generic Name | TRULIGHT 5520 |
| Product Code | FQP |
| Date Received | 2017-05-19 |
| Model Number | 1574851 |
| 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 07318 SAALFELD, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-05-19 |