MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-06 for EMPRINT CA15L2 manufactured by Covidien Lp - Superdimension Inc.
[178102079]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178102080]
According to the reporter, during an ablation for metastatic wilm? S disease, the ceramic tip fell off while removing the antenna from the patient. The tip remained inside the patient. No surgery done to remove the tip. The doctor was planning to do an mri on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2020-00010 |
| MDR Report Key | 9678369 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2019-10-31 |
| Date Added to Maude | 2020-02-06 |
| 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 LP - SUPERDIMENSION INC |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| 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 | 2020-02-06 |
| Model Number | CA15L2 |
| Catalog Number | CA15L2 |
| Lot Number | S9KG015X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Address | 161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-06 |