POWER CONTROL 2303011Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04055207056653), received between Apr 12, 2019 and Jul 1, 2026 — classified as 9 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Failure to Power Up

  IT WAS REPORTED THAT THE MORCELLATOR POWER UNIT MALFUNCTIONED, AND A VISUAL MESSAGE DISPLAYED ON THE SCREEN; 'CAUTION! "POWER CONTROL" DEVICE ERROR! THERE HAVE BEEN NO REPORTS OF INJURIES OR UNACCEPTABLE RISKS TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682796 ↗
• MalfunctionJun 19, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING A HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURE, THE MOTOR CONTROL UNIT MALFUNCTIONED. MULTIPLE ATTEMPTS AT TRYING TO RESOLVED THE ISSUE DID NOT PRODUCE A SUCCESSFUL OUTCOME. A VISUAL MESSAGE SAYING "CAUTION! POWER CONTROL DEVICE ERROR! PLEASE CONTACT AUTHORIZED SERVICE TECHNICIAN" CONTINUED TO BE DISPLAYED ON THE SCREEN IN CONJUNCTION WITH A HIGH PITCHED AUDIBLE ERROR TONE. THE SUCTION UNIT MAINTAINED FUNCTIONALITY. THERE HAVE BEEN NO REPORTS OF INJURIES OR UNACCEPTABLE RISKS TO THE PATIENT OR OTHER PERSONNEL. THE PLANNED PROCEDURE WAS PERFORMED SUCCESSFULLY, HOWEVER, WITH A 10-MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562509 ↗
• InjuryJun 11, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING A HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURE, THE MOTOR CONTROL UNIT FAILED. A VISUAL MESSAGE IN GERMAN LANGUAGE DISPLAYS ON THE SCREEN. TRANSLATION: "'CAUTION! "POWER CONTROL" DEVICE ERROR!". ALSO, ADVISING USER TO CONTACT AN AUTHORIZED SERVICE TECHNICIAN. ANYTIME IT IS TURNED ON IT WILL SOUND THE ALARM WITH THE VISUAL MESSAGE DISPLAY. THE REPORTED "POWER CONTROL ERROR" ISSUE CAUSED A DELAY OF APPROXIMATELY TWO-HOUR DURING THE SURGERY AND PLACED THE PATIENT AT RISK DUE TO PROLONGED ANESTHESIA. THE ISSUE OCCURRED AT THE END OF THE PROCEDURE AND DID NOT RESULT IN ANY INJURIES TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477786 ↗
• InjuryJun 11, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING A HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURE, THE MOTOR CONTROL UNIT FAILED. A VISUAL MESSAGE IN GERMAN LANGUAGE DISPLAYS ON THE SCREEN. TRANSLATION: "'CAUTION! "POWER CONTROL" DEVICE ERROR!". ALSO, ADVISING USER TO CONTACT AN AUTHORIZED SERVICE TECHNICIAN. ANYTIME IT IS TURNED ON IT WILL SOUND THE ALARM WITH THE VISUAL MESSAGE DISPLAY. THE REPORTED "POWER CONTROL ERROR" ISSUE CAUSED A DELAY OF APPROXIMATELY TWO-HOUR DURING THE SURGERY AND PLACED THE PATIENT AT RISK DUE TO PROLONGED ANESTHESIA. THE ISSUE OCCURRED AT THE END OF THE PROCEDURE AND DID NOT RESULT IN ANY INJURIES TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477691 ↗
• MalfunctionJun 11, 2026Failure to Power Up

  IT WAS REPORTED THAT THE MORCELLATOR SYSTEM FAILED IMMEDIATELY AFTER PRIMING SUCTION AND COMPLETING A SYSTEM TEST WITH THE HANDPIECE CONNECTED. MULTIPLE ATTEMPTS AT TRYING TO RESOLVED THE ISSUE DID NOT PRODUCE A SUCCESSFUL OUTCOME. A VISUAL MESSAGE SAYING "CAUTION! POWER CONTROL DEVICE ERROR! PLEASE CONTACT AUTHORIZED SERVICE TECHNICIAN" CONTINUED TO BE DISPLAYED ON THE SCREEN IN CONJUNCTION WITH A HIGH PITCHED ERROR TONE AND ILLUMINATED RED ERROR INDICATOR. THE SUCTION UNIT MAINTAINED FUNCTIONALITY. THERE ARE NO REPORTS OF INJURIES OR UNACCEPTABLE RISKS, AND THE PROCEDURE WAS PERFORMED WITHOUT DELAY; HOWEVER, THIS MALFUNCTION OCCURRED PRIOR TO THE PROCEDURE ON THE PATIENT, SO NO ADDITIONAL MEASURES WERE TAKEN BEYOND THE ORIGINAL PROCEDURE. THE PHYSICIAN DECIDED TO SWITCH FROM LASER ENUCLEATION TO TRANSURETHRAL RESECTION OF THE PROSTATE; BOTH PROCEDURES ARE MINIMALLY INVASIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25475400 ↗
• InjuryJun 9, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING A HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURE, THE MOTOR CONTROL UNIT FAILED. A VISUAL MESSAGE IN GERMAN LANGUAGE DISPLAYS ON THE SCREEN. TRANSLATION: "'CAUTION! "POWER CONTROL" DEVICE ERROR!". ALSO, ADVISING USER TO CONTACT AN AUTHORIZED SERVICE TECHNICIAN. ONCE THESE VISUAL DISPLAYS THE MACHINE IS NO LONGER FUNCTIONAL. ANYTIME IT IS TURNED ON IT WILL SOUND THE ALARM WITH THE VISUAL MESSAGE DISPLAY. THE REPORTED "POWER CONTROL ERROR" ISSUE CAUSED A DELAY OF APPROXIMATELY TWO-HOUR DELAY OF THE SURGERY, REMOVING THE SPECIMEN MANUALLY. ACCORDING TO THE USER, PATIENT WAS PLACED UNDER SEDATION LONGER THAN NECESSARY AND THIS RESULTED IN AN INCREASED RISK OF BLADDER INJURY FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449070 ↗
• InjuryJun 9, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING A HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURE, THE MOTOR CONTROL UNIT FAILED. A VISUAL MESSAGE IN GERMAN LANGUAGE DISPLAYS ON THE SCREEN. TRANSLATION: "'CAUTION! "POWER CONTROL" DEVICE ERROR!". ALSO, ADVISING USER TO CONTACT AN AUTHORIZED SERVICE TECHNICIAN. ONCE THESE VISUAL DISPLAYS THE MACHINE IS NO LONGER FUNCTIONAL. ANYTIME IT IS TURNED ON IT WILL SOUND THE ALARM WITH THE VISUAL MESSAGE DISPLAY. THE REPORTED "POWER CONTROL ERROR" ISSUE CAUSED A DELAY OF APPROXIMATELY TWO-HOUR DELAY OF THE SURGERY, REMOVING THE SPECIMEN MANUALLY. ACCORDING TO THE USER, PATIENT WAS PLACED UNDER SEDATION LONGER THAN NECESSARY AND THIS RESULTED IN AN INCREASED RISK OF BLADDER INJURY FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449055 ↗
• InjuryJun 9, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING A HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURE, THE MORCELLATOR POWER UNIT FAILED AND A VISUAL MESSAGE DISPLAYED ON THE SCREEN; 'CAUTION! "POWER CONTROL" DEVICE ERROR! ALSO, THE VISUAL MESSAGE ADVISING USER TO CONTACT A SERVICE TECHNICIAN. THERE ARE NO REPORTS OF INJURIES OR UNACCEPTABLE RISKS; HOWEVER, THE CLIENT REPORTS THAT THE "POWER CONTROL ERROR" ISSUE CAUSED A DELAY OF APPROXIMATELY ONE AND A HALF HOURS AND REQUIRED AN ADDITIONAL MEDICAL PROCEDURE USING A BIPOLAR ELECTRODE TO REMOVE THE TISSUE INSTEAD OF THE MORCELLATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449044 ↗
• InjuryJun 9, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING A HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURE, THE MORCELLATOR POWER UNIT FAILED AND A VISUAL MESSAGE DISPLAYED ON THE SCREEN; 'CAUTION! "POWER CONTROL" DEVICE ERROR!" ALSO, THE VISUAL MESSAGE ADVISING USER TO CONTACT A SERVICE TECHNICIAN. THERE ARE NO REPORTS OF INJURIES OR UNACCEPTABLE RISKS; HOWEVER, THE CLIENT REPORTS THAT THE "POWER CONTROL ERROR" ISSUE CAUSED A DELAY OF APPROXIMATELY ONE AND A HALF HOURS AND REQUIRED AN ADDITIONAL MEDICAL PROCEDURE USING A BIPOLAR ELECTRODE TO REMOVE THE TISSUE INSTEAD OF THE MORCELLATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449010 ↗
• MalfunctionMay 4, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A MORCELLATION PROCEDURE, THE MORCELLATOR UNIT STOPPED WORKING ONCE INSIDE THE PATIENT. THE SUCTION WOULD WORK BUT NOT THE PIRANHA SYSTEM. THE MORCELLATOR UNIT WAS TESTED SEVERAL TIMES BY THE SPECIALISTS AND WAS FOUND TO BE FULLY FUNCTIONAL. LATER, IT WAS DETERMINED THAT IT WAS A TECHNICAL ERROR ON THE TECHNICIAN SIDE. THERE WAS NO REPORTED DELAY, AND THE SCHEDULED PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073053 ↗
• MalfunctionAug 13, 2025Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT DURING MORCELLATION, (HOLEP) PROCEDURE, THE BLADES WERE NOT ROTATING IN THE HANDLE. UPON CHANGING TO A DIFFERENT MACHINE, THE BLADE ROTATED, AND THE HANDLE WORKED. THERE WAS NO REPORTED DELAY AND THE SCHEDULED PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795259 ↗
• MalfunctionJul 9, 2025Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT DURING A PROCEDURE, THE MOTOR CONTROL UNIT STOPPED DELIVERING POWER TO THE HANDPIECE. THE REPORTED ISSUE CAUSED A 5 MINUTE DELAY IN THE PROCEDURE WHILE RETRIEVING ANOTHER MACHINE TO COMPLETE THE SCHEDULED PROCEDURE. THE DELAY DID NOT PUT THE PATIENT AT UNACCEPTABLE RISK. THERE WAS NO ADDITIONAL TREATMENT OR PROCEDURE NEEDED. THERE IS NO REPORT OF ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459088 ↗
• InjuryMar 13, 2025Suction Failure; Suction Failure

  ACCORDING TO THE INFORMATION RECEIVED, THE SUCTION PUMP, PART 2208011, SN# (B)(6), STOPPED WORKING DURING A HOLEP PROCEDURE. THE REPORTED PROBLEM CAUSED THE PROCEDURE TO BE CANCELLED AFTER A DELAY OF APPROX. 2 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600589 ↗
• InjuryFeb 20, 2024Failure to Cut; Poor Visibility; Failure to Cut; Poor Visibility

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE, AT THE START OF MORCELLATION DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, THE BLADES WERE NOT BITING ANY OF THE TISSUE NOR SUCKING THE TISSUE TOWARD THE BLADES. DURING THIS TIME, VISUALIZATION WAS POOR AND LOST DISTENSION A COUPLE OF TIMES AND UNFORTUNATELY NICKED THE BLADDER TWICE. THE SURGEON ABORTED THE PROCEDURE AND CHANGE TO A STANDARD TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE TO COMPLETE THE CASE. AN ADDITIONAL PROCEDURE WAS NEEDED TO REPAIR THE PATIENT'S BLADDER. LATER, THE INITIAL REPORTER CLARIFIED THAT THE SUCTION TO THE CANISTERS WAS WORKING FINE. THE BLADES WOULD NOT HOLD OR BITE THE TISSUE. THE OPERATION TIME WAS PROLONGED BY 90 MINUTES DUE TO THE SURGICAL STAFF TRYING TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18743618 ↗
• InjuryJan 5, 2022Suction Failure; Suction Failure

  IT WAS REPORTED TO RICHARD WOLF: THERE WAS A LACK OF ENGAGEMENT BETWEEN THE PIRANHA AND THE PROSTATE TISSUE. WHILE TRYING TO CAPTURE THE FREED PROSTATE TISSUE THE BLADDER WAS CAUGHT INSTEAD. WE TRIED A DIFFERENT HANDLE, PIRANHA MACHINE, BLADE, AND CANISTER AND EXPERIENCED THE SAME ISSUE A SECOND TIME. THE CASE WAS COMPLETED BUT DR. SLOAN HAD TO REMOVE THE REMAINING TISSUE WITH A GRASPER AND LENGTHY LASERING. NO REPAIRS TO THE BLADDER WERE MADE. A THIRD MACHINE AND TWO DIFFERENT HANDLES WERE USED ON THE NEXT TWO CASES WITH NO PROBLEMS. TRANSCRIPT OF VOICEMAIL LEFT BY SALES MANAGER: THE PERSON I'M WITH TODAY DR. (B)(6) HAD AN INJURY WHERE THERE WASN'T ENOUGH SUCTION COMING FROM THE MACHINE. SO IT WASN'T ENGAGING THE PROSTATE TISSUE AND IN ATTEMPTING TO GET THE PROSTATE TISSUE INTO/TO ENGAGE THE MORCELLATOR THERE WAS SOME BLADDER TISSUE THAT WAS CAPTURED INSTEAD. SO WE SWITCHED THE SCOPES, MACHINES, HANDLE, AND CANISTERS AND USED THE PIRANHA AGAIN. IT HAPPENED AGAIN, SAME THING, THERE WASN'T ENOUGH SUCTION TO ENGAGE THE PROSTRATE TISSUE AND IT GATHERED BLADDER TISSUE INSTEAD. SO IT CUT THAT PATIENT TWICE. I THINK I HAVE DISCOVERED WHAT THE PROBLEM IS: SPD DEPARTMENT BANGING PIRANHA HA

  Patient problems: Laceration(s)

  MAUDE report 13172323 ↗
• MalfunctionAug 10, 2021Decrease in Suction; Decrease in Suction

  THE PURPOSE OF THIS SUBMISSION IS TO CLOSE THIS MEDICAL DEVICE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304681 ↗
• MalfunctionJul 28, 2021Device Displays Incorrect Message; Connection Problem; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Connection Problem; Appropriate Device Problem Term/Code Not Available

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE EVALUATION. THE DEVICE WAS EVALUATED USING VISUAL AND FUNCTIONAL MEANS. THE REPORTED CONDITION, MACHINE WOULD GO BACK TO TREATMENT MODE AND SAY CHECK FOR LEAKS OR PRESSURE, WAS NOT CONFIRMED. NO DEVICE PROBLEM (2303.011 - MOTOR CONTROL UNIT) FOUND. FINDINGS AS REPORTED BY THE MANUFACTURER: ACCORDING TO THE MANUFACTURER, THE "MOTOR CONTROL UNIT 2303.011 WAS TESTED, ALSO IN COMBINATION OF THE DEVICE FROM CMPT (B)(4) (1418479-2021-00034) SUCTION PUMP. NO DEFECT OF THE MOTOR CONTROL UNIT 2303.011 WAS DETECTED. THE MOTOR CONTROL UNIT 2303.011 WORKS PROPERLY. THE REPORTED ISSUES WAS CAUSED BY THE DEVICE FROM COMPLAINT (B)(4) (1418479-2021-00034). THE DEVICE WAS RETURNED TO THE CUSTOMER..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12241657 ↗
• MalfunctionNov 3, 2020Suction Problem; Suction Problem

  RWMIC DEVICE EVALUATION (B)(6) 2021: DURING THE INSPECTION OF THE MOTOR CONTROL UNIT TYPE 2303011 NO DEFECT/ERROR COULD BE DETECTED. THE FOOT SWITCH TYPE 2030108 MUST NOT BE ACTUATED UNTIL "READY FOR USE" APPEARS ON THE DISPLAY OF THE TYPE 2208011, OTHERWISE THE ERROR MESSAGE "FOOTSWITCH IN USE/ DEFECTIVE PLEASE CHECK" APPEARS, SEE GA-A252 CHAPTER 7. I. IT IS HIGHLY PROBABLE THAT THE FOOTSWITCH IS ACTUATED DURING VACUUM BUILDUP OR THAT THE VACUUM IS TOO LOW. PIRANHA MODE OR SUCTION MODE CANNOT BE ACTIVATED ERROR "FOOT SWITCH DEFECTIVE" CHECK FOR CORRECT TUBE CONNECTIONS. THE REPORTED CONDITIONS COULD NOT BE CONFIRMED, THEREFORE NO FURTHER ACTIONS WILL BE CARRIED OUT.

  Patient problems: Insufficient Information

  MAUDE report 10779301 ↗
• MalfunctionSep 15, 2020Overheating of Device; Overheating of Device

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. ACCORDING TO INVESTIGATION REPORT - DEVICE EVALUATION: DEVICE EVALUATION WAS CONDUCTED USING VISUAL, FUNCTIONAL, MECHANICAL AND ELECTRICAL TESTING. THE HOUSING OF THE DEVICE WAS SO BADLY BENT THAT IT HAD TO BE STRAIGHTENED FIRST TO GET THE HOUSING OF THE DEVICE OPEN. SHORT CIRCUIT IN THE MEMBRANE KEYBOARD, BURN HOLE IN THE FRONT MEMBRANE. THERE ARE IMAGES AVAILABLE. THE REPORTED CONDITION WAS CONFIRMED. AS FOR PRODUCT DISPOSITION, THAT NEEDS TO BE CLARIFIED WITH THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10538490 ↗
• MalfunctionSep 15, 2020Overheating of Device; Overheating of Device

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. RW GMBH RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FUNCTIONALLY, VISUALLY AND MECHANICALLY EVALUATED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE DEVICE WAS CHECKED, NO ERRORS FOUND. NO ACTIONS WERE TAKEN. THE DEVICE MET SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10538489 ↗
• MalfunctionJun 17, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ON (B)(6) 2019, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED THE FOLLOWING INFORMATION: DURING MORCELATTION, UNIT STOPPED WORKING. THERE WAS A TRIANGLE ERROR CODE AND THE ALARM WENT OFF. THERE WAS NO PATIENT INJURY AND THE CASE WAS NOT COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10163697 ↗
• MalfunctionJul 26, 2019Computer Software Problem; Computer Software Problem

  ON (B)(6) 2019, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED REPORT REGARDING THE TWO COMPONENTS OF THE PIRANHA SYSTEM: MOTOR CONTROL UNIT PART # 2303.011 - TO BE REPORTED IN MDR 1418479-2019-00031, SUCTION PUMP PART # 2208011 - TO BE REPORTED IN MDR 1418479-2019-00032. IT WAS REPORTED THAT THE PUMP FOR THE PIRANHA IS DEFECTIVE. PHOTOS WERE PROVIDED AND SHOWED THAT THE PUMP PRESENTED WITH "VACUUM SENSOR DEFECTIVE" AND "DEVICE DEFECTIVE" ERROR CODES. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2019 BY THE INITIAL REPORTER: THE MALFUNCTION OCCURRED DURING THE MIDDLE OF A PROCEDURE. THE MACHINE WAS TURNED OFF AND BACK ON IN AN ATTEMPT TO RESOLVE THE ISSUE. ADDITIONALLY, THE TUBING, FILTERS, PROSTATE COLLECTION CANISTER, AS WELL AS THE LIDS ON THE FLUID CANISTERS AND FLUID CANISTERS, WERE CHANGED. THERE WERE CRACKS ON THE FLUID COLLECTING CANISTERS NOTICED, THE CANISTERS WERE SUBMERGED IN WATER LATER TO CONFIRM THAT THERE WERE NO CRACKS PRESENT. AS A RESULT OF THE MALFUNCTION THE SURGEON HAD TO CONVERT THE PROCEDURE TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) AFTER THEY HAD ALREADY ENUCLEATED THE PROSTATE. THE PROSTATE TISSUE FLOATING IN THE BLA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8833476 ↗
• MalfunctionApr 12, 2019Pumping Problem; Unexpected Shutdown; Pumping Problem; Unexpected Shutdown

  THE USER FACILITY RETURNED THE DEVICE TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) ON MARCH 12, 2019 AND THE DEVICE EVALUATION WAS COMPLETED ON JULY 09, 2019. THE DEVICE WAS VISUALLY, FUNCTIONALLY, AND ELECTRICALLY EVALUATED. THE REPORTED CONDITION COULD NOT BE VERIFIED, THE INSPECTION OF THE MOTOR CONTROL UNIT DID NOT REVEAL ANY FUNCTION PROBLEMS. THE DEVICE MET SPECIFICATIONS AND THERE WAS NO MANUFACTURING DEFECT IDENTIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511437 ↗