POWER STICK M4 8564021Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04055207017982), received between Jan 27, 2022 and May 29, 2026 — classified as 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Suction Failure

  IT WAS REPORTED THAT THE HANDPIECE HAS FAILED TO PROVIDE THE INTENDED SUCTION DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. HOWEVER, THE REPORTED ISSUE CAUSED A 20 - 30 MINUTES DELAY IN THE PROCEDURE WHILE THE USER HAVE ATTEMPTED TO TROUBLESHOOT THE HANDPIECE. THE DOCTOR EVENTUALLY SHIFTED TO USING BIPOLAR LOOP RESECTION TO BREAK APART TISSUE INTO SMALLER PIECES THEN USED THE ELLIK EVACUATOR TO REMOVE THEM. THE SCHEDULED PROCEDURE WAS COMPLETED, AND NO ADDITIONAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334288 ↗
• MalfunctionMay 29, 2026Suction Failure

  IT WAS REPORTED THAT THE HANDPIECE HAS FAILED TO PROVIDE THE INTENDED SUCTION DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. HOWEVER, THE REPORTED ISSUE CAUSED A 20 - 30 MINUTES DELAY IN THE PROCEDURE WHILE THE USER HAVE ATTEMPTED TO TROUBLESHOOT THE HANDPIECE. THE DOCTOR EVENTUALLY SHIFTED TO USING BIPOLAR LOOP RESECTION TO BREAK APART TISSUE INTO SMALLER PIECES THEN USED THE ELLIK EVACUATOR TO REMOVE THEM. THE SCHEDULED PROCEDURE WAS COMPLETED, AND NO ADDITIONAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334249 ↗
• MalfunctionMar 17, 2026Decrease in Suction

  IT WAS REPORTED THAT THE INSTRUMENT HAS FAILED TO PROVIDE THE INTENDED SUCTION DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE. DURING THE MORCELLATION PART OF PROCEDURE, WHEN THE SURGEON WAS PUSHING SUCTION ON THE FOOT SWITCH, IT WAS NOT REGISTERING VERY MUCH SUCTION. THEY SWAPPED THE HEADPIECE OUT AND PROCEDURE CONTINUED AS NORMAL. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621821 ↗
• MalfunctionJan 14, 2026Suction Failure

  IT WAS REPORTED THAT THE INSTRUMENT HAS LOST SUCTION AT THE BEGINNING OF THE MORCELLATION PROCEDURE. A SIMILAR BACK-UP DEVICE WAS UTILIZED, AND THE SCHEDULED PROCEDURE WAS COMPLETED WITH MINIMAL DELAY. THERE WAS NO ADDITIONAL MEDICAL TREATMENT OR PROCEDURE REQUIRED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24074413 ↗
• InjuryDec 29, 2025Decrease in Suction; Decrease in Suction

  ACCORDING TO THE INFORMATION RECEIVED, THE INSTRUMENT FAILED TO PROVIDE SUFFICIENT SUCTION DURING A LASER ENUCLEATION OF PROSTATE W/ MORCELLATION PROCEDURE. THE USER ALSO REPORTED LACK OF CLEAR VISION. ALTHOUGH THERE IS NO REPORT OF INJURY OR ILLNESS TO THE PATIENT, THE REPORTED ISSUE CAUSED A DELAY OF APPROXIMATELY 1 HOUR WHILE REPLACING THE DEVICE. THE SCHEDULED PROCEDURE WAS COMPLETED, AND NO ADDITIONAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917434 ↗
• InjuryDec 29, 2025Decrease in Suction; Decrease in Suction

  ACCORDING TO THE INFORMATION RECEIVED, THE INSTRUMENT FAILED TO PROVIDE SUFFICIENT SUCTION DURING A LASER ENUCLEATION OF PROSTATE W/ MORCELLATION PROCEDURE. THE USER ALSO REPORTED LACK OF CLEAR VISION. ALTHOUGH THERE IS NO REPORT OF INJURY OR ILLNESS TO THE PATIENT, THE REPORTED ISSUE CAUSED A DELAY OF APPROXIMATELY 1 HOUR WHILE REPLACING THE DEVICE. THE SCHEDULED PROCEDURE WAS COMPLETED, AND NO ADDITIONAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917433 ↗
• MalfunctionDec 29, 2025Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE INSTRUMENT HAS LOST SUCTION DURING THE END OF THE PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. HOWEVER, THE REPORTED ISSUE CAUSED A 25 - 35 MINUTES DELAY IN THE PROCEDURE WHILE THE USER HAVE ATTEMPTED MULTIPLE TIMES TO FLUSH THE HANDPIECE. THE SCHEDULED PROCEDURE WAS COMPLETED, AND NO ADDITIONAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23916671 ↗
• InjurySep 15, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ACCORDING TO THE INFORMATION RECEIVED, THERE IS A REPORT OF AN INJURY THAT OCCURRED DURING THE PROCEDURE. IT WAS REPORTED THAT THE USER USED A DEFECTIVE DEVICE THAT WAS REMOVED ASIDE BY THE USER PRIOR TO USE. SOMEONE MUST HAVE TAKEN THE HANDPIECE THAT WAS SET ASIDE AND STERILIZED IT FOR THE CASE. WHILE THEY WERE WORKING, THE BLADDER WAS PERFORATED.

  Patient problems: Perforation

  MAUDE report 23052604 ↗
• InjurySep 15, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  ACCORDING TO THE INFORMATION RECEIVED, THERE IS A REPORT OF AN INJURY THAT OCCURRED DURING THE PROCEDURE. IT WAS REPORTED THAT THE USER USED A DEFECTIVE DEVICE THAT WAS REMOVED ASIDE BY THE USER PRIOR TO USE. SOMEONE MUST HAVE TAKEN THE HANDPIECE THAT WAS SET ASIDE AND STERILIZED IT FOR THE CASE. WHILE THEY WERE WORKING, THE BLADDER WAS PERFORATED.

  Patient problems: Perforation

  MAUDE report 23052561 ↗
• MalfunctionJul 8, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE MOTOR CONTROL UNIT DETECTED THE HANDPIECE INTERMITTENTLY, THEN STOPPED BEING DETECTABLE. THE HANDPIECE WAS CHECKED AND FOUND NOT FUNCTIONING PROPERLY WITH THE CABLE OR MOTOR CONTROL UNIT. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. HOWEVER, THE REPORTED ISSUE CAUSED A 15 MINUTE DELAY IN THE PROCEDURE WHILE OBTAINING ANOTHER SECOND MOTOR CONTROL UNIT, M4 HANDPIECE AND MORCELLATOR CABLE TO COMPLETE THE SCHEDULED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436929 ↗
• InjuryJul 1, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT, DURING THE MIDDLE OF THE MORCELLATION PROCESS, THE GENERATOR STOPPED AND TRIGGERED THE ALARM. THE USER RESTARTED THE EQUIPMENT. HOWEVER, THE ALARM CONTINUED AND FAILED TO STOP. THE SURGERY WAS CANCELLED AND INSTEAD A PROSTATE PROBE WAS PERFORMED. THE PATIENT WAS RESCHEDULED FOR SURGERY ON (B)(6) 2025 FOR A PROSTATIC ADENOMA. THERE ARE NO REPORTS OF HEALTH PROBLEMS AND PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371510 ↗
• InjuryOct 1, 2024Suction Failure; Suction Failure

  A MEDICAL DISTRIBUTOR HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A MOTOR HANDPIECE MAX. 6000RPM, PART ID: 8564.021, SN # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, AFTER THE LASER ENUCLEATION OF THE PROSTATE WAS COMPLETED, THE HEALTH PROFESSIONAL TRIED TO USE THE POWER STICK FOR MORCELLATION AND SUCTION. THE MOTORIZED HANDPIECE WORKED BRIEFLY FOR 5-10 SECONDS, THEN SUCTION FAILED. THE HANDPIECE WAS CHECKED AND RELOADED PROBE/BLADE. ALSO, CONNECTIONS OF THE STERILE DISPOSABLE TUBING, FILTER, AND CANISTER WERE CHECKED SEVERAL TIMES. HOWEVER, THE SUCTION COULD NOT BE GENERATED, AND THEREFORE SURGERY WAS ABANDONED. THE PATIENT RETURNED THE FOLLOWING DAY WITH AN ACUTE CONDITION. A SECOND HANDPIECE WAS USED WITH THE SAME MOTOR CONTROL UNIT 2304 AND THE SUCTION AND MORCELLATION WAS COMPLETED. LATER INFORMATION RECEIVED CONFIRMED THAT THE PATIENT HAS NO NEGATIVE MEDICAL EVENTS AFTER THE FIRST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347489 ↗
• InjuryJan 24, 2024Suction Failure; Suction Failure

  A MEDICAL SUPPLIER HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A MOTOR HANDPIECE MAX. 6000RPM, PART ID: 8564.021, SN # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, DURING THE OPERATION (MORCELLATION OF THE PROSTATE), THE MOTORIZED HANDLE FAILED SO THAT NO VACUUM COULD BE GENERATED. THE SCHEDULED PROCEDURE WAS COMPLETED. HOWEVER, THE OPERATION TIME WAS EXTENDED BY AN HOUR. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573542 ↗
• MalfunctionNov 15, 2023Suction Failure; Suction Failure

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) OF AN ISSUE REGARDING A MOTOR HANDPIECE MAX. 6000RPM, PART ID: 8564.021, SN # (B)(6) . ACCORDING TO THE CUSTOMER, THE HANDPIECE LOST SUCTION NEAR THE END OF A HOLEP PROCEDURE. THE REPORTED ISSUE CAUSED A 30 MINUTE DELAY DURING THE PROCEDURE TO CHANGE DISPOSABLES OF THE SYSTEM. THE SCHEDULED PROCEDURE WAS COMPLETED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140264 ↗
• MalfunctionNov 3, 2023Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A MOTOR HANDPIECE MAX. 6000RPM, PART ID: 8564.021, SN # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, THE HANDPIECE MAKES A STRANGE NOISE, BECOMES HOT DURING OPERATION AND DOES NOT FUNCTION PROPERLY. THE SCHEDULED PROCEDURE WAS COMPLETED AND NO ADDITIONAL, UNFORESEEN MEDICAL MEASURES HAD TO BE TAKEN. HOWEVER, THERE WAS AN APPROXIMATELY 2 HOUR TIME DELAY IN THE OPERATING ROOM. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. NO UNEXPECTED SIDE EFFECTS AND THE GENERAL HEALTH CONDITION OF THE PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066595 ↗
• InjuryJan 31, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO RICHARD WOLF (B)(4) BY RICHARD WOLF MIC THAT A SALES REP REPORTED THAT "HAND PIECES WOULD NOT HOLD TISSUE." RESPONSES TO QUESTIONS FROM THE DEVICE COMPLAINT FORM - INITIAL REPORT. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. EMAIL CORRESPONDENCE WITH CUSTOMER SERVICE (1/19/2022) HOW LONG WAS EACH DELAY? FOR PART 8564.021 S/N (B)(4): 5 MINUTES. FOR PART 8564.021 S/N (B)(4): 45 MINUTES. WHAT ACTIONS WERE BEING DONE DURING EACH DELAY? NEW TRAY WAS GRABBED DURING FIRST DELAY. PATIENT HAD TO BE PREPPED FOR AN OPEN PROCEDURE CONVERSION AFTER SECOND DELAY. WHAT WERE THE RISKS TO THE PATIENTS? PATIENT HAD TO BE OPENED UP TO REMOVE TISSUE. DID THE PATIENTS REQUIRE ANY ADDITIONAL TREATMENT DURING THE DELAY OR WILL REQUIRE ANOTHER PROCE

  Patient problems: Embolism/Embolus

  MAUDE report 13399807 ↗
• InjuryJan 31, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO RICHARD WOLF (B)(4) BY RICHARD WOLF MIC THAT A SALES REP REPORTED THAT "HAND PIECES WOULD NOT HOLD TISSUE." RESPONSES TO QUESTIONS FROM THE DEVICE COMPLAINT FORM - INITIAL REPORT: WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. EMAIL CORRESPONDENCE WITH CUSTOMER SERVICE ((B)(6)2022). HOW LONG WAS EACH DELAY? FOR PART 8564.021 S/N (B)(4): 5 MINUTES. FOR PART 8564.021 S/N (B)(4): 45 MINUTES. WHAT ACTIONS WERE BEING DONE DURING EACH DELAY? NEW TRAY WAS GRABBED DURING FIRST DELAY. PATIENT HAD TO BE PREPPED FOR AN OPEN PROCEDURE CONVERSION AFTER SECOND DELAY. WHAT WERE THE RISKS TO THE PATIENTS? PATIENT HAD TO BE OPENED UP TO REMOVE TISSUE. DID THE PATIENTS REQUIRE ANY ADDITIONAL TREATMENT DURING THE DELAY OR WILL REQUIRE ANOTHER PRO

  Patient problems: Embolism/Embolus

  MAUDE report 13399629 ↗
• InjuryJan 28, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO RICHARD WOLF BY THE SALES REP THAT "HAND PIECES WOULD NOT HOLD TISSUE." RESPONSES TO QUESTIONS FROM THE DEVICE COMPLAINT FORM - INITIAL REPORT WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. EMAIL CORRESPONDENCE WITH CUSTOMER SERVICE (1/19/2022): HOW LONG WAS EACH DELAY? FOR PART 8564.021 S/N (B)(4): 5 MINUTES. FOR PART 8564.021 S/N (B)(4): 45 MINUTES. WHAT ACTIONS WERE BEING DONE DURING EACH DELAY? NEW TRAY WAS GRABBED DURING FIRST DELAY. PATIENT HAD TO BE PREPPED FOR AN OPEN PROCEDURE CONVERSION AFTER SECOND DELAY. WHAT WERE THE RISKS TO THE PATIENTS? PATIENT HAD TO BE OPENED UP TO REMOVE TISSUE. DID THE PATIENTS REQUIRE ANY ADDITIONAL TREATMENT DURING THE DELAY OR WILL REQUIRE ANOTHER PROCEDURE AS THE RESULT OF THE DELAY? PAT

  Patient problems: Embolism/Embolus

  MAUDE report 13384905 ↗
• InjuryJan 27, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO RICHARD WOLF BY THE SALES REP THAT "HAND PIECES WOULD NOT HOLD TISSUE." RESPONSES TO QUESTIONS FROM THE DEVICE COMPLAINT FORM - INITIAL REPORT. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. EMAIL CORRESPONDENCE WITH CUSTOMER SERVICE (1/19/2022): HOW LONG WAS EACH DELAY? FOR PART 8564.021 S/N (B)(4): 5 MINUTES. FOR PART 8564.021 S/N (B)(4): 45 MINUTES. WHAT ACTIONS WERE BEING DONE DURING EACH DELAY? NEW TRAY WAS GRABBED DURING FIRST DELAY. PATIENT HAD TO BE PREPPED FOR AN OPEN PROCEDURE CONVERSION AFTER SECOND DELAY. WHAT WERE THE RISKS TO THE PATIENTS? PATIENT HAD TO BE OPENED UP TO REMOVE TISSUE. DID THE PATIENTS REQUIRE ANY ADDITIONAL TREATMENT DURING THE DELAY OR WILL REQUIRE ANOTHER PROCEDURE AS THE RESULT OF THE DELAY? PA

  Patient problems: Embolism/Embolus

  MAUDE report 13372842 ↗