MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2020-03-02 for NCIRCLE TIPLESS STONE EXTRACTOR NTSE-022115-UDH manufactured by Cook Inc.
[182924625]
(b)(6). Occupation: sales representative. Pma/510k #? 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
[182924626]
It was reported, prior to the start of a ureteroscopy and laser lithotripsy procedure, the handle of an ncircle tipless stone extractor was discovered broken upon opening the package. The device was not used. It is unknown how the procedure was completed. No adverse events have been reported as a result of the alleged malfunction. Additional information has been requested regarding the event. At the time of this report, no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00512 |
| MDR Report Key | 9774362 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2018-12-05 |
| Date Added to Maude | 2020-03-02 |
| 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 | MRS. JENNIFER CANADA |
| 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 | NCIRCLE TIPLESS STONE EXTRACTOR |
| Generic Name | FFL DISLODGER, STONE, BASKET, URETERAL, METAL |
| Product Code | FFL |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2020-03-19 |
| Catalog Number | NTSE-022115-UDH |
| Lot Number | 9358436 |
| 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 | 2020-03-02 |