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 |