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 2017-09-26 for N-COMPASS NITINOL STONE EXTRACTOR N/A C-NTSE-2.4-115-NC3 manufactured by Cook Inc.
[87863861]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[87863862]
The customer reported that, during a common bile duct exploration (cbde) procedure, the basket of the n-compass nitinol stone extractor did not open. No additional procedures were reportedly required, and no patient adverse events were reported. The circumstances surrounding the usage and handling of the device are not known. The product has been received for evaluation; however, as of the date of this report, the investigation is still pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-03222 |
| MDR Report Key | 6893723 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-26 |
| Date of Report | 2018-01-31 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2018-01-17 |
| Date Added to Maude | 2017-09-26 |
| 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 | 8128294891 |
| 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 | 2017-09-26 |
| Model Number | N/A |
| Catalog Number | C-NTSE-2.4-115-NC3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-09-26 |