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 2020-01-07 for EMPRINT CA15L2 manufactured by Covidien Medical Products.
[173943399]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[173943400]
According to the reporter, during ablation, the antenna was completely reinserted a total of two times, repositioned twice per insertion, and one additional minor adjustment but the tip of the probe broke while in the patient body after providing 5 ablations. The physician had decided to leave the tip in the patient body with patient's consent. Computed tomography (ct) scan located the tip within the liver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006451981-2020-00005 |
| MDR Report Key | 9558482 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2019-12-30 |
| Device Manufacturer Date | 2019-09-29 |
| Date Added to Maude | 2020-01-07 |
| 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 | 2020-01-07 |
| Model Number | CA15L2 |
| Catalog Number | CA15L2 |
| Lot Number | S9JG027X |
| 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 | 1. Required No Informationntervention | 2020-01-07 |