MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2014-10-22 for NCOMPASS NITINOL TIPLESS STONE EXTRACTOR UNK manufactured by Cook, Inc..
[21445037]
As reported by a fellow physician, the physician used an ncompass in the ureter when grabbed too large of a stone and couldn't release it from the basket. The physician attempted to pull the basket in an attempt to release the stone and the basket broke. There was many wire fragments in the ureter and the physician was unable to remove them all. The physician placed a ureteral stent and the two doctors will be seeing the pt for a second procedure this (b)(6) 2014. The physician believes the pt is doing okay and did not seen anything unusual and later did a ct scan. Some fragments remain in the pt.
Patient Sequence No: 1, Text Type: D, B5
[21620609]
(b)(4). Event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[51155934]
A review of complaint history, instructions for use (ifu), quality control, and trends was conducted during the investigation. The complaint device was not returned for investigation the lot number and specific device are unknown. Quality control 100% confirms smooth operation of the device through inspection and that its free of any damages. An ifu is included with the device and includes "important excessive force could damage the device. " based on customer testimony, it is likely to suggest that the basket experienced excessive forces leading to the breakage of the basket wires. Per the conclusion of quality engineering risk assessment, additional risk reduction is not required. We have notified appropriate internal personnel and will continue to monitor for similar events.
Patient Sequence No: 1, Text Type: N, H10
[51155935]
Per the physician, the f/u procedure went well and there were no complications to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2014-00536 |
| MDR Report Key | 4217517 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2014-10-22 |
| Date of Report | 2014-09-30 |
| Date Mfgr Received | 2014-10-01 |
| Date Added to Maude | 2014-11-03 |
| 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 | RITA HARDEN, DIRECTOR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NCOMPASS NITINOL TIPLESS STONE EXTRACTOR |
| Generic Name | GAE SNARE, SURGICAL |
| Product Code | GAE |
| Date Received | 2014-10-22 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-22 |