MalfunctionGEI
UNKNOWN VALLEYLAB PRODUCT
Received Jan 8, 2019 · Event occurred Nov 30, 2018
Report 1717344-2019-00046 · MDR key 8229233
Device
Generic name
Electrosurgical, Cutting & Coagulation & Accessories
Manufacturer
CovidienModel number
UNKNOWN VALLEYLAB PRODUCTCatalog number
UNKNOWN VALLEYLAB PRODUCT
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Injury
- Burn, Thermal
- Injury
- Burn, Thermal
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF CYSTOSCOPY WITH URETHRAL DILATION, TRANSURETHRAL RESECTION/ABLATION OF PROSTATE WITH BIPOLAR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED THERMAL INJURY TO HIS BLADDER AND URETHRA.