MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-25 for N-COMPASS NITINOL STONE EXTRACTOR C-NTSE-2.4-115-NCT4 manufactured by Cook Inc.
[115058941]
Non-healthcare professional. (b)(4). 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
[115058942]
It was reported a patient underwent ureteroscopy with stone extraction. The physician attempted to retrieve a stone using a n-compass nitinol stone extractor that was too large for the basket. The basket was unable to be removed, therefore, he removed the handle and pulled off the scope. It was further stated that the plan was to retrieve the basket and laser the stone on monday, (b)(6) 2018. The device was removed as planned. The basket was removed through sequential dilation over an existing wire with an access sheath and 3. 6 french ureteroscope and laser lithotripsy with a 200 micron fiber. The basket was then pulled out alongside the sheath. The patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02089 |
| MDR Report Key | 7720775 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-25 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2018-07-25 |
| 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 | 2018-07-25 |
| Model Number | NA |
| Catalog Number | C-NTSE-2.4-115-NCT4 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2018-07-25 |