MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for ILED TRIPLE 1565161 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[119670309]
It is known that improper installation, maintenance or a collision can lead to the spring arm joint cover falling. The device is still being investigated by an olympus (b)(4) technician. A follow-up report will be submitted if new pertinent information is obtained.
Patient Sequence No: 1, Text Type: N, H10
[119670310]
During a neurological procedure, the plastic strip of a iled triple's ac3000 arm joint cover fell on the patient. There were no reports of any injury to the patient or impact to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2018-00046 |
| MDR Report Key | 7850320 |
| Date Received | 2018-09-06 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2011-01-25 |
| Date Added to Maude | 2018-09-06 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ILED TRIPLE |
| Generic Name | SURGICAL LIGHT |
| Product Code | FQP |
| Date Received | 2018-09-06 |
| Model Number | 1565161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-09-06 |