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 2019-04-24 for N-COMPASS NITINOL STONE EXTRACTOR N/A C-NTSE-2.4-115-NCT4 manufactured by Cook Inc.
[144151803]
(b)(6). Pma/510(k) #: 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
[144151804]
It was reported that the basket of the n-compass nitinol stone extractor would not open fully during an endoscopic retrograde cholangio-pancreatography (ercp) procedure. The basket was found to be working properly when tested outside of the patient. However, when inside the patient during the procedure, the basket would not fully open. After a few unsuccessful attempts, a new basket was used to complete the procedure. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00898 |
| MDR Report Key | 8546145 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2019-04-24 |
| Date of Report | 2019-06-14 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-05-28 |
| Device Manufacturer Date | 2018-12-14 |
| Date Added to Maude | 2019-04-24 |
| 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 | MR. LARRY POOL |
| 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 | N-COMPASS NITINOL STONE EXTRACTOR |
| Generic Name | GAE SNARE, SURGICAL |
| Product Code | GAE |
| Date Received | 2019-04-24 |
| Returned To Mfg | 2019-05-22 |
| Model Number | N/A |
| Catalog Number | C-NTSE-2.4-115-NCT4 |
| Lot Number | 9346195 |
| 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 | 2019-04-24 |