MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for PLASMABLADE 3.0S PS210-030S manufactured by Medtronic Advanced Energy, Llc.
[185985175]
Product analysis #: 703652291: analysis information 2020-03-12, 11:34:03 cst, pli#: 20; product id#: ps210-030s. Analysis summary: complaint confirmed: upon receiving the device, the heat shrink component was torn and coming off the blade. The device was visually confirmed for this analysis. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185985176]
Information was received from a manufacturing representative (rep) regarding a handpiece. It was reported that the tip coating was coming off the tip of the handpiece. The site opened a new hand piece to continue with the case. There was no patient involvement and the rep was transferred to service and repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2020-00048 |
| MDR Report Key | 9903774 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-12-05 |
| Date Added to Maude | 2020-03-31 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASMABLADE 3.0S |
| Generic Name | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
| Product Code | GEI |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-10 |
| Model Number | PS210-030S |
| Catalog Number | PS210-030S |
| Lot Number | 0218983091 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |