MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2018-08-29 for OPEN-END FLEXI-TIP URETERAL CATHETER 021305 manufactured by Cook Inc.
[118893980]
Pma/510(k) # - pre-amendment. (b)(4). 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
[118893981]
It was reported via sus event report number mw5078977: patient underwent cystoscopy. During the procedure, surgeon used an open-ended catheter in patient's left ureter. The surgeon threaded the catheter through the scope. After using the catheter, he attempted to remove it, but had difficulty pulling it out through the scope. After pulling out the catheter, the patient's bladder was inspected, two shavings were visualized from the catheter in the bladder. Both shavings were removed. Procedure completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02612 |
| MDR Report Key | 7828246 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2018-08-29 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2018-04-25 |
| Date Added to Maude | 2018-08-29 |
| 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 | OPEN-END FLEXI-TIP URETERAL CATHETER |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-08-29 |
| Catalog Number | 021305 |
| Lot Number | 8841289 |
| 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 | 2018-08-29 |