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 |