MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-31 for NCIRCLE TIPLESS STONE EXTRACTOR NTSE-022115-UDH manufactured by Cook Urological Inc.
[21314198]
During use of a ncircle tipless stone extractor to retrieve a stone, the basket broke off. Another manufacturer's device was used to retrieve the basket parts. Another basket was opened to complete the procedure. A section of the device did not remain inside the patient's body. According to the initial reporter, the patient did not experience any adverse effects due tot his occurrence.
Patient Sequence No: 1, Text Type: D, B5
[21577366]
(b)(4). Event is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00441 |
| MDR Report Key | 3471944 |
| Report Source | 07 |
| Date Received | 2013-10-31 |
| Date of Report | 2013-10-04 |
| Date of Event | 2013-09-27 |
| Date Facility Aware | 2013-09-27 |
| Report Date | 2013-10-04 |
| Date Mfgr Received | 2013-10-09 |
| Device Manufacturer Date | 2013-04-15 |
| Date Added to Maude | 2013-11-18 |
| 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 | 0 |
| 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 | NCIRCLE TIPLESS STONE EXTRACTOR |
| Product Code | GAE |
| Date Received | 2013-10-31 |
| Returned To Mfg | 2013-10-22 |
| Model Number | NA |
| Catalog Number | NTSE-022115-UDH |
| Lot Number | U2332527 |
| ID Number | NA |
| Device Expiration Date | 2016-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL INC |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-31 |