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 2019-05-08 for ENDOFLIP EF-322N manufactured by Crospon Ltd.
[146650688]
Evaluation summary: this report is based on information provided by medtronic investigation personnel. One ef-322n was received for evaluation. The returned sample met specification as received by medtronic. The customer reported that catheter not supported in software. The reported condition was not confirmed. The investigation found the device to function normally and within specifications. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[146650689]
According to the reporter, when they connected the catheter, they received an error message "catheter not supported/catheter not con ected" and the syringe holder was not moving to the correct position for the catheter to fit, but there was no issue with the syringe plunger. It took three catheters to get this done and the machine was turned off and turned on and the catheter was disconnected and reconnected to see if that would fix the problem, but it did not. Technical support confirmed that the catheter connector was inserted with the green dots aligned. The catheter display did not have a real-time clock battery depleted/cmos error, there was an issue with archiving the data, but not the current problem, and the catheter was not difficult to remove from the patient. The catheter will be returned for investigation. There was no patient and user harm, but they required additional anesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006897778-2019-00008 |
| MDR Report Key | 8593218 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-08 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-01-11 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-05-08 |
| 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 | ENDOFLIP |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2019-05-08 |
| Returned To Mfg | 2019-02-20 |
| Model Number | EF-322N |
| Catalog Number | EF-322N |
| Lot Number | 322N180718 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-05-08 |