MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-21 for EMPRINT CA15L2 manufactured by Covidien Medical Products.
[180441530]
One device was received for evaluation. The returned product did not meet specification as received. Visual inspection found that part of the outer antenna shaft was removed and not returned. The inner tube was bent in multiple locations. The reported condition was confirmed. The investigation found that part of the outer antenna shaft was removed and not returned. The inner tube was bent in multiple locations. This break is not consistent with normal use. The investigation identified the probable cause of the reported event to be willful user damage. The instructions for use (ifu) states, do not apply excessive lateral or rotational force during insertion or extraction of the antenna. Doing so may lead to breakage of the antenna and injury to the patient or user. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[180441531]
The device was returned without any accompanying complaint information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006451981-2020-00026 |
| MDR Report Key | 9741541 |
| Report Source | OTHER |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-21 |
| 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 | 2020-02-21 |
| Returned To Mfg | 2020-01-21 |
| Model Number | CA15L2 |
| Catalog Number | CA15L2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-21 |