MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-11 for THD REVOLUTION 800133 manufactured by Thd Spa.
[90297463]
The thd system involved in the event is based on the doppler-guided location and ligation of the terminal branches of the superior haemorrhoidal artery using the thd evolution or thd revolution devices and their compatible single-use kits. Then, thd evolution and thd revolution devices are used in conjunction with dedicated instruments, such as thd kit, thd fiber optic cable and thd doppler probe. In particular, in the thd system, the fiber optic cable is connected to the thd evolution and thd revolution devices and, by coupling the tip on the handle of the thd slide proctoscope, it acts as an illuminator of the operating field. We have considered as object of this report the only device part of the system not disposed by the facility at the end of the treatment (thd revolution).
Patient Sequence No: 1, Text Type: N, H10
[90297465]
At the end of the procedure, the surgeon found a superficial burnt on the patient skin. The procedure was completed successfully and the patient burn wound was dressed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006680097-2017-00001 |
| MDR Report Key | 6940807 |
| Date Received | 2017-10-11 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-08-26 |
| Date Mfgr Received | 2017-09-11 |
| Device Manufacturer Date | 2014-01-13 |
| Date Added to Maude | 2017-10-11 |
| 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. MAURIZIO PANTALEONI |
| Manufacturer Street | VIA INDUSTRIA 1 |
| Manufacturer City | CORREGGIO, REGGIO EMILIA 42015 |
| Manufacturer Country | IT |
| Manufacturer Postal | 42015 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THD REVOLUTION |
| Generic Name | THD REVOLUTION |
| Product Code | JAF |
| Date Received | 2017-10-11 |
| Returned To Mfg | 2017-09-29 |
| Model Number | 800133 |
| Lot Number | 00002514 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THD SPA |
| Manufacturer Address | VIA INDUSTRIA 1 CORREGGIO, REGGIO EMILIA 42015 IT 42015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-11 |