MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-25 for VERSAPULSE POWERSUITE 60W 0638-804-01 manufactured by Lumenis Ltd..
| Report Number | 3004135191-2020-00033 |
| MDR Report Key | 9876590 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-20 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2014-03-13 |
| Date Added to Maude | 2020-03-25 |
| 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. YOAV WIMISNER |
| Manufacturer Street | 6 HAKIDMA ST. PO BOX 240 |
| Manufacturer City | YOKNEAM, 20692 |
| Manufacturer Country | IS |
| Manufacturer Postal | 20692 |
| Manufacturer G1 | LUMENIS LTD. |
| Manufacturer Street | 6 HAKIDMA ST. PO BOX 240 |
| Manufacturer City | YOKNEAM, 20692 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSAPULSE POWERSUITE 60W |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT |
| Product Code | GEX |
| Date Received | 2020-03-25 |
| Model Number | VERSAPULSE POWERSUITE 60W |
| Catalog Number | 0638-804-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMENIS LTD. |
| Manufacturer Address | 6 HAKIDMA ST. PO BOX 240 YOKNEAM, 20692 IS 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |