MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-04 for TRULIGHT 5320 1583715 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[122633869]
A trumpf medical authorized service technician evaluated the light and, he recommended that the damaged components be replaced. Our investigation has identified steps in the manufacturing process which can lead to the paint chipping. The damage to the painted surfaces usually does not develop suddenly, but develops over time. The instructions for use state that the devices must be checked for proper condition prior to each use. Damaged devices must not be used. If damage to the surface coating is recognized and removed, there is no danger to the patient. The surface coating process will be updated to include additional testing and verification.
Patient Sequence No: 1, Text Type: N, H10
[122633870]
The paint coating was found to be flaking from a trumpf medical surgical light lamp head. No patient or caregiver injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2018-00049 |
| MDR Report Key | 7933495 |
| Report Source | USER FACILITY |
| Date Received | 2018-10-04 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2011-02-21 |
| Date Added to Maude | 2018-10-04 |
| 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 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRULIGHT 5320 |
| Generic Name | SURGICAL LIGHT |
| Product Code | FQP |
| Date Received | 2018-10-04 |
| Model Number | 1583715 |
| 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 | 2018-10-04 |