MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-02-10 for NGAGE NITINOL STONE EXTRACTOR NGE-017115 manufactured by Cook Inc.
[178330096]
Pma/510k #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[178330097]
It was reported, during a transuretheral lithotripsy (tul) procedure using ngage nitinol stone extractor, the basket was unable to capture the stones. After confirming the stones were in view, the user attempted three times to capture the stones, but the grasping force was weak and they were unable to. Another nge-017715 was used to complete the procedure instead. There were no adverse effects to the patient due to the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00316 |
| MDR Report Key | 9686252 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-11-04 |
| Date Added to Maude | 2020-02-10 |
| 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 | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NGAGE NITINOL STONE EXTRACTOR |
| Generic Name | FFL DISLODGER, STONE, BASKET, URETERAL, METAL |
| Product Code | FFL |
| Date Received | 2020-02-10 |
| Returned To Mfg | 2020-02-24 |
| Catalog Number | NGE-017115 |
| Lot Number | 10126628 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-10 |