SHARK/S-LINE

Additional Manufacturer Narrative

THE PRESENT 46300243 BIVAP ELECTRODE BIPO 24-26FR 12/30° FROM THE BATCH 21002383 WAS CHECKED IN THE RESPONSIBLE TECHNICAL DEPARTMENT. THE 46300243 BIVAP ELECTRODE BIPO 24-26FR 12/30° FROM THE LOT 21002383 WAS PRODUCED ON 29/04/2020. THE LOT 21002383 CONSISTS OF 41 BIVAP ELECTRODES BIPO 24-26FR 12/30°. TO THE CUSTOMER 2 PAK OF 46300243 BIVAP ELECTRODE BIPO 24-26FR 12/30° WERE DELIVERED ON 12/11/2020. THERE HAVE BEEN NO FURTHER COMPLAINTS FROM LOT 21002383 SO FAR. DUE TO THE DETECTED DEFECTS / DAMAGES AT THE 46300243 BIVAP ELECTRODE BIPO 24-26FR 12/30° FROM THE LOT 21002383 WE ASSUME INCREASED WEAR AND TEAR DURING USE. A PRODUCT OR MANUFACTURING DEFECT COULD NOT BE DETECTED. THE INSTRUCTION FOR USE GA342 S-LINE SALINE RESECTOSCOPE INSTRUCTIONS FOR USE EXPLICITLY REFER TO THIS TYPE OF WEAR AND TEAR. CHAPTER 7.2.4 HF APPLICATION CAUTION! THERMAL DAMAGE MAY BE CAUSED IF THE VAPORIZATION ELECTRODE IS PERMANENTLY ACTIVATED! HIGH LEVELS OF HEAT OR DISTAL WEAR TO THE ELECTRODE INSULATION MAY BE THE RESULT. WHEN USING THE VAPORIZATION ELECTRODE, THE FOLLOWING SHOULD BE OBSERVED: NO PERMANENT ACTIVATION OF THE VAPORIZATION ELECTRODE ACTIVATION AND PAUSE PHASES SHOULD BE IMPLEMENTED IN THE SAME WAY AS WHEN USING A CUTTING ELECTRODE THE VAPORIZATION ELECTRODE SHOULD ONLY BE ACTIVATED WHEN IN CONTACT WITH LARGE AREAS OF TISSUE. POSSIBLE HAZARDS WERE TAKEN INTO ACCOUNT IN THE RISK ASSESMENT BB2-3 REV 05 WITH THE CORRESPONDING EXTENT OF DAMAGE AND PROBABILTY OF OCCURANCE AND ASSESSED WITH AN ACCEPTABLE RISK. THIS ASSESSMENT IS STILL VALID EVEN TAKING INTO ACOUN THE CURRENT CASE. RICHARD WOLF GMBH (RWGMBH) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWGMBH RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) SUBMITTING REPORT ON BEHALF OF RWGMBH REPORT ON BEHALF OF RWGMBH.

Description of Event or Problem

THIS FOLLOW UP REPORT IS TO PROVIDE THE COMPLAINT INVESTIGATION. THE FULL DESCRIPTION OF THE FINDINGS IS PROVIDED IN THE SECTION H10 OFTHIS REPORT.

Additional Manufacturer Narrative

THE INVESTIGATION OF THE COMPLAINT IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED AFTER THE DEVICE EVALUATION HAS BEEN COMPLETED AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE. RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF (B)(4).

Description of Event or Problem

ON DECEMBER 14, 2020 RICHARD WOLF (B)(4) WAS INFORMED BY RW (B)(4) ABOUT AN ADVERSE EVENT. AFTER ABOUT 45 MINUTES OF VAPORISATION WITH THE DISPOSABLE ELECTRODE, THE BUTTON SUDDENLY DETACHED FROM THE ELECTRODE AND THE BROKEN-OFF PART WAS LOST IN THE BLADDER. AFTER A PAINSTAKING SEARCH, THE 2 MM BUTTON WAS FOUND IN THE BLADDER AND FINALLY FLUSHED OUT. THE USER NEEDED ABOUT 20 MINUTES FOR RECOVERY.