MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-09 for ESOFLIP ES-330 manufactured by Crospon Ltd.
[141359862]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[141359863]
According to the reporter, the catheter failed when they were trying to start a procedure. The syringe would not load properly and they got a temperature sensor failure error. A repeat procedure was necessary with additional anesthesia and the customer stated that they did not insert the catheter into the patient, but they did use another catheter without issue. There was no reported patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006897778-2019-00006 |
| MDR Report Key | 8495507 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-09 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-09-23 |
| Date Added to Maude | 2019-04-09 |
| 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 | CROSPON LTD |
| Manufacturer Street | GALWAY BUSINESS PARK, DANGAN |
| Manufacturer City | GALWAY,FL H91P2DK |
| Manufacturer Postal Code | H91P2DK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOFLIP |
| Generic Name | ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS |
| Product Code | PIE |
| Date Received | 2019-04-09 |
| Returned To Mfg | 2019-03-22 |
| Model Number | ES-330 |
| Catalog Number | ES-330 |
| Lot Number | 3300180202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSPON LTD |
| Manufacturer Address | GALWAY BUSINESS PARK, DANGAN GALWAY,FL H91P2DK H91P2DK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-09 |