MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for ULTIMA OPCAB SYSTEM, STANDARD BLADE C-OM-2001S manufactured by Maquet Cardiovascular Llc.
[141434235]
(b)(4). A lot history record review was completed for the reported product lot number. There were no ncmr? S for the reported lot number. The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[141434236]
The hospital reported that during preparation for a coronary artery bypass procedure, ultima opcab system, standard blade remained stuck on the packaging upon opening. A replacement device was used to complete the procedure. No clinical consequences were reported so far. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242352-2019-00401 |
| MDR Report Key | 8490955 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-05 |
| Date Mfgr Received | 2019-06-18 |
| Device Manufacturer Date | 2018-08-22 |
| Date Added to Maude | 2019-04-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | ULTIMA OPCAB SYSTEM, STANDARD BLADE |
| Generic Name | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
| Product Code | DWS |
| Date Received | 2019-04-08 |
| Returned To Mfg | 2019-04-04 |
| Catalog Number | C-OM-2001S |
| Lot Number | 25140948 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-08 |