MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for ULTIMA ACTIVATOR II REUSABLE DRIVE MECH UA-5001 manufactured by Maquet Cardiovascular Llc.
[185285197]
Trackwise id#(b)(4). Since the device is not available to be returned to us, a technical evaluation cannot be performed. Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
Patient Sequence No: 1, Text Type: N, H10
[185285198]
The hospital reported that during a coronary artery bypass procedure using ultima activator ii reusable drive mech, they noticed the damage of the ultima activator. As the retractor handle broke and dislocated from its original position during the time of procudure and no patient harm reported. A replacement device was used to complete the procedure. The hospital did not report any patient effects..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242352-2020-00316 |
| MDR Report Key | 9888294 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-10-28 |
| Date Added to Maude | 2020-03-27 |
| 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 Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer G1 | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTIMA ACTIVATOR II REUSABLE DRIVE MECH |
| Generic Name | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
| Product Code | DWS |
| Date Received | 2020-03-27 |
| Model Number | ULTIMA ACTIVATOR II REUSABLE DRIVE MECH |
| Catalog Number | UA-5001 |
| Lot Number | 25148706 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Address | 45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |