MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-20 for TRULIGHT 4038120 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[63312535]
The device was visually inspected by a local service technician and the device was not returned to trumpf medical. It was discovered that the caster brakes at the base of the mobile light were engaged at the time of the incident and cause the light to fall when the user attempted to move the light. If new relevant information becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[63312536]
The arm of the mobile light tilted down causing the light head to fall onto the patient. The light head struck the patient on the right ankle breaking the sterile field. No medical treatment was required as a result of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2016-00015 |
| MDR Report Key | 6190867 |
| Date Received | 2016-12-20 |
| Date of Report | 2016-11-28 |
| Date of Event | 2016-11-28 |
| Date Mfgr Received | 2016-11-28 |
| Device Manufacturer Date | 2013-04-02 |
| Date Added to Maude | 2016-12-20 |
| 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 | TRULIGHT |
| Generic Name | TRULIGHT MOBILE |
| Product Code | FSS |
| Date Received | 2016-12-20 |
| Model Number | TRULIGHT |
| Catalog Number | 4038120 |
| 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 | 2016-12-20 |