PIRANHA

Additional Manufacturer Narrative

SINCE THE INSTRUMENTS/DEVICES ARE NOT BEING SENT IN FOR EXAMINATION, RICHARD WOLF GMBH CAN ONLY SPECULATE ON THE FOLLOWING CAUSES FOR THE CLOGGING OF THE BLADES: AS THE CLOGGED ROTARY BLADES COULD BE DISASSEMBLED AGAIN FOR CLEANING AFTER THE TESTS, I DO NOT BELIEVE THAT THE INNER BLADE IS SEIZED INSIDE THE OUTER BLADE. OTHERWISE, THE INNER BLADE WOULD HAVE REMAINED STUCK INSIDE THE OUTER BLADE AND COULD NOT HAVE BEEN DISASSEMBLED AGAIN, OR ONLY WITH CONSIDERABLE FORCE. HOWEVER, THE BLADES CAN BECOME CLOGGED FOR THE FOLLOWING REASONS: 1. BLADES FULLY OPEN DURING THE INITIAL SUCTION OF THE FABRIC - THE REDUCED BLADE OPENING WAS IMPLEMENTED IN THE PIRANHA 1.0 PRIMARILY TO PREVENT PREMATURE CLOGGING OF THE BLADE, ESPECIALLY RIGHT AT THE FIRST CUT. THE ADVANTAGE OF THE CLOSED BLADE WAS ALSO DEMONSTRATED IN THE LABORATORY USING THE PIRANHA 1.0 SYSTEM. IN THE IFU GA-A202 / EN / INT / V2.0 / 2025-08 /, WE PROVIDE THE FOLLOWING INFORMATION ON THIS: STOP POSITION OF THE INNER BLADE: ONLY A SMALL GAP NEXT TO THE BLADE IS OPEN, GAP WIDTH APPROX. 1 MM. MAKE THE SETTING AS DESCRIBED IN 12.3.3 SETTING THE PARAMETERS WITH THE FOOTSWITCH CONNECTED. 2. RECOMMENDED SPEED SETTING ON THE CONTROL UNIT NOT FOLLOWED. THE BLADES SHOULD, OF COURSE, NOT BE OPERATED DRY, BUT ONLY WITH FLUSHING FLUID. THE USER MANUAL CONTAINS THE FOLLOWING WARNING REGARDING THIS: TYPICAL SPEEDS FOR ROTARY BLADES: 100-1500 RPM. RECOMMENDED SPEED FOR ROTARY BURRS: 800-3000 RPM (IN SPECIAL CASES UP TO 6000 RPM; ONLY POWER STICK M4). EFFICIENT SPEED FOR OSCILLATION MODE: 100-1500 RPM. ATTENTION: WORK ONLY WITH THE RECOMMENDED SPEED SETTINGS AND UNDER CONTINUOUS IRRIGATION. IF THE SPEED SETTING IS TOO HIGH OR IF OPERATED WITHOUT IRRIGATION, THE INTERNAL BLADE CAN SEIZE UP OR WEAR RAPIDLY OR CLOG IF THE SPEED SETTING IS TOO LOW. IF THE SUCTION CHANNEL IS CLOGGED BY TISSUE PARTS, MORCELLATION IS ADVERSELY AFFECTED. CLEAN A CLOGGED SUCTION CHANNEL WITH A SUITABLE CLEANING BRUSH (SEE SECTION MANUAL REPROCESSING). FOR EACH USE, HAVE A SPARE ROTATION MORCELLATOR AT HAND. 3. ESPECIALLY WHEN USING THE POWER STICK M4 MOTORIZED HANDLE, WE RECOMMEND FULLY OPENING THE VALVE ON THE MOTORIZED HANDLE TO PREVENT CLOGGING OF THE BLADE OR THE MOTORIZED HANDLE. TO PREVENT CLOGGING, WE ALSO RECOMMEND USING SEAL INSERT 15178145. 12.3.7 POWER STICK M4 WITH OPEN SEALING INSERT. POSITIONING THE ROTARY BLADE: CUTTING WINDOW OPEN / CLOSED, SEE SECTION 12.3.4 SETTING THE PARAMETERS ON THE POWER CONTROL, WITH NO FOOTSWITCH CONNECTED. OPEN SEALING INSERT (14.2): THE VALVE IS ALWAYS OPEN (SUCTION) AND CANNOT BE ADJUSTED. NOTE: IN CONJUNCTION WITH THE OPEN SEALING INSERT (15178145), THE POWER STICK M4 MAY ONLY BE USED FOR UROLOGICAL APPLICATIONS. POTENTIAL RISKS WERE TAKEN INTO ACCOUNT IN THE EE5-4 REV.00 RISK ASSESSMENT (NON-REUSABLE TOOLS), ALONG WITH THE CORRESPONDING SEVERITY AND PROBABILITY OF OCCURRENCE AND WERE DEEMED ACCEPTABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE DISPOSABLE BLADE, TYPE 49700113, HAD JAMMED AFTER A FEW MINUTES INTO THE PROCEDURE. A NEW PACKAGE OF DISPOSABLE BLADES HAD TO BE OPENED, BUT AFTER A FEW MINUTES, THIS BLADE ALSO JAMMED AND COULD NOT BE UNJAMMED. BECAUSE OF THIS SITUATION, THE PROCEDURE COULD NOT BE COMPLETED USING THE PIRANHA SYSTEM. THE SPECIALIST HAD TO PERFORM OPEN SURGERY ON THE PATIENT TO COMPLETE THE SCHEDULED PROCEDURE.