MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-16 for TRULIGHT TRULIGHT 5520 1574850 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[60554023]
The handle adapter was reassembled and repaired by a trumpf medical technician.
Patient Sequence No: 1, Text Type: N, H10
[60554024]
At the start a procedure an or tech attempted to apply a sterile handle to the surgical light adapter handle. The silver button and spring which locks the sterile handle on the adapter handle became loose and fell into the sterile field. This occurred prior to the incision being made. The patient was re-prepped and re-draped causing an approximate 10 minute delay to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2016-00012 |
| MDR Report Key | 6106626 |
| Date Received | 2016-11-16 |
| Date of Report | 2016-10-20 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2016-10-20 |
| Device Manufacturer Date | 2013-04-24 |
| Date Added to Maude | 2016-11-16 |
| 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 | MS. KAREN CAMPBELL |
| Manufacturer Street | 1046 LEGRAND BLVD |
| Manufacturer City | CHARLESTON SC 29492 |
| Manufacturer Country | US |
| Manufacturer Postal | 29492 |
| Manufacturer Phone | 8434161361 |
| Manufacturer G1 | TRUMPF MEDIZIN SYSTEME GMBH + CO. KG |
| Manufacturer Street | CARL-ZEISS STRASSE 7-9 |
| Manufacturer City | 07318 SAALFELD, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRULIGHT |
| Generic Name | TRULIGHT 5510 |
| Product Code | FQP |
| Date Received | 2016-11-16 |
| Model Number | TRULIGHT 5520 |
| Catalog Number | 1574850 |
| 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 07318 SAALFELD, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-16 |