MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-17 for TRULIGHT TRULIGHT 5500 4038310 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[60687765]
The light head is secured by a retaining segment at the spring arm. To prevent the retaining segment from dislodging, a sleeve covers the retaining segment. When our local partner evaluated the light in order to investigate the incident, it was found that the sleeve is staying in the raised position, instead of covering the retaining segment. Thus, the locking /retaining segment, not covered by the sleeve, as a result dislodged from its normal position resulting the cardanic arm and the spring arm disconnection. Root cause for this incident is determined to be a screw that was not completely seated after a servicing event, which prevented the protective sleeve from lowering therefore allowing the retaining segment to dislodge. All of the facility's or's and the lightheads were evaluated per our maintenance check list in the presence of the hospital biomedical group. The lighthead will be replaced due to damage incurred in the fall.
Patient Sequence No: 1, Text Type: N, H10
[60687766]
A trumpf medical ceiling mounted surgical light separated at the cardanic - spring arm joint and fell to the floor during an operation. A trumpf medical service technician found that the retaining sleeve on the spring arm was in the uppermost position, allowing the retaining segment to back out. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2016-00013 |
| MDR Report Key | 6109242 |
| Date Received | 2016-11-17 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2016-10-18 |
| Device Manufacturer Date | 2013-09-12 |
| Date Added to Maude | 2016-11-17 |
| 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 |
| 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, SAALE 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 5500 |
| Product Code | FQP |
| Date Received | 2016-11-17 |
| Model Number | TRULIGHT 5500 |
| Catalog Number | 4038310 |
| Device Availability | N |
| 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 | 2016-11-17 |