BIVAP ELECTRODE BIPO
Received Jan 10, 2019 · Event occurred Nov 30, 2016
Report 1418479-2018-00054 · MDR key 8238012
Device
Generic name
Bivap Electrode Bipo
Manufacturer
Richard Wolf GmbhModel number
46300243Catalog number
46300243
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
58 YR
- Burn, Thermal
- Burn, Thermal
Narrative
Additional Manufacturer Narrative
RWMIC CONSIDERS THIS CASE OPEN. THE USER FACILITY AND MANUFACTURER WILL BE CONTACTED AGAIN IN AN EFFORT TO COLLECT MISSING INFORMATION.
Description of Event or Problem
ON (B)(6) 2018, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) WAS SERVED WITH A PATIENT LAW SUIT INVOLVING A "BUTTON TYPE BIPOLAR PROSTATE RESECTOR AND/OR ELECTROSURGICAL GENERATOR". ON (B)(6) 2016, THE PATIENT UNDERWENT A PROCEDURE DESCRIBED AS "CYSTOSCOPY WITH URETHRAL DILATION, TRANSURETHRAL RESECTION/ABLATION OF PROSTATE WITH BIPOLAR". DURING SAID PROCEDURE, THE PATIENT WAS UNDER GENERAL ANESTHESIA AND SUFFERED THERMAL INJURY TO THEIR BLADDER AND URETHRA. AT THIS TIME, THE INVOLVEMENT OF RICHARD WOLF PRODUCTS HAS NOT BEEN CONFIRMED. HOWEVER, THE FOLLOWING ARE CONSIDERED SUSPECT PRODUCTS AND MDRS WILL BE SUBMITTED FOR EACH UNTIL THE USER FACILITY IS ABLE TO CONFIRM THAT NO RICHARD WOLF PRODUCTS WERE INVOLVED: 8680.225 WORKING ELEMENT PASSIVE BIPO 0/12/30 (MDR 1418479-2018-00051), 8680.224 WORKING ELEMENT PASSIVE BIPO 0/12/30 (MDR 1418479-2018-00052), 46300223 BIVAP ELECTRODE BIPO 22FR 12/30 (MDR 1418479-2018-00053), 46300243 BIVAP ELECTRODE BIPO 24-26FR 12/30 (MDR).