MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2015-11-11 for TRULIGHT 4038120 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[30981916]
Trumpf medical was made aware by the spring arm supplier that 12 spring arms sold to trumpf medical may have an out of specification weld. This device was under a field corrective action at the time of the failure. The spring arm involved in this event was impacted by that field action and had not yet been replaced. The devices included in this field action were not sold in the united states.
Patient Sequence No: 1, Text Type: N, H10
[30981917]
The joint of the spring arm component of the mobile surgical light failed. The spring arm and light head became detached from the stand and fell during a surgical case. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2015-00013 |
| MDR Report Key | 5217443 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2015-11-11 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-10-13 |
| Date Mfgr Received | 2015-10-13 |
| Device Manufacturer Date | 2012-04-23 |
| Date Added to Maude | 2015-11-11 |
| 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 | HOSPITAL SERVICE TECHNICIAN |
| 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 | 9367158641 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRULIGHT |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | FSS |
| Date Received | 2015-11-11 |
| Model Number | 4038120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-11-11 |