MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-11-13 for EMPRINT CA20L2 manufactured by Covidien Medical Products.
[166318868]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[166318869]
According to the reporter, pre-operatively, air was accumulated in the tube, priming was unable to be performed. Another device was used and it worked fine. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006451981-2019-00228 |
| MDR Report Key | 9319302 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2019-11-13 |
| Date of Report | 2019-11-13 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2019-10-28 |
| Device Manufacturer Date | 2019-06-22 |
| Date Added to Maude | 2019-11-13 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | COVIDIEN MEDICAL PRODUCTS |
| Manufacturer Street | BUILDING 10- NO 789 PUXING ROA |
| Manufacturer City | SHANGHAI 201114 |
| Manufacturer Country | CN |
| Manufacturer Postal Code | 201114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMPRINT |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2019-11-13 |
| Model Number | CA20L2 |
| Catalog Number | CA20L2 |
| Lot Number | S9FG008X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MEDICAL PRODUCTS |
| Manufacturer Address | BUILDING 10- NO 789 PUXING ROA SHANGHAI 201114 CN 201114 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-13 |