MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for OPEN-END FLEXI-TIP URETERAL CATHETER manufactured by Cook Incorporated.
[122657596]
It was reported via occurrence report that during procedure there was a device malfunction; the laser bridge for the resectoscope sheared off a piece of the pollack catheter inside of the patient's bladder. Patients bladder was irrigated and foreign body was not found, suspected to have washed out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080273 |
| MDR Report Key | 7926258 |
| Date Received | 2018-10-01 |
| Date Added to Maude | 2018-10-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPEN-END FLEXI-TIP URETERAL CATHETER |
| Generic Name | CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-10-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-01 |