NA 2232641Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04055207056523), received between Sep 11, 2017 and Dec 4, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2020Mechanical Problem; Mechanical Problem

  ON (B)(6) 2020, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): THE UNIT STOPPED FUNCTIONING IN THE MIDDLE OF A PROCEDURE. THERE WAS NO PATIENT OF STAFF INJURY. MACHINE HAD A MECHANICAL ERROR AND COULD NOT GET IT TO FUNCTION. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE 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? (ONLY APPLICABLE IF THERE WAS A REPORT OF DELAY) NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10949851 ↗
• MalfunctionFeb 7, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  USER FACILITY RETURNED THE DEVICE TO RWMIC ON 01/24/2020 AND RWMIC SEND THE DEVICE TO THE MANUFACTURER FOR EVALUATION ON 02/07/2020. RWMIC ALSO REACHED OUT TO THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION BUT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9682270 ↗
• MalfunctionMar 11, 2019Power Problem; Power Problem

  ON 24 AUGUST 2018, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED MEDWATCH REPORT # (B)(4). THE FOLLOWING WAS REPORTED: "PATIENT SCHEDULED FOR A TRANSANAL ENDOSCOPIC MICROSURGICAL EXCISION OF THE RECTAL TUMOR USING THE WOLF TEM MACHINE. THE PATIENT WAS INTUBATED AND A PROCTOSIGMOIDOSCOPY WAS PERFORMED BY THE SURGEON AND THEN THE PATIENT WAS POSITIONED AND PREPPED FOR SURGERY. WHEN IT CAME TIME TO START THE MACHINE ONLY THE TOP UNIT WAS LIGHTING UP AND WORKING (INSUFFLATOR). THE BOTTOM UNIT DID NOT TURN ON. OTHER STAFF CAME INTO THE ROOM TO TROUBLESHOOT THE PROBLEM WITH NO LUCK GETTING THE BOTTOM UNIT TO TURN ON. THE WOLF REP, AND TEAM LEADER WAS CALLED TO HELP TROUBLESHOOT. AT THIS TIME THE SURGEON WANTED TO ABORT THE CASE." THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE SALES REPRESENTATIVE WENT TO THE USER FACILITY TO INVESTIGATE THE REPORTED ISSUE AND FOUND THAT THE CAUSE OF THE PROBLEM WAS A DEFECTIVE OUTLET. THE UNIT WAS PLUGGED INTO A DIFFERENT OUTLET AND BEGAN WORKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8407943 ↗
• MalfunctionNov 21, 2018Unexpected Shutdown; Unexpected Shutdown

  ON OCTOBER 23, 2018, THE USER FACILITY REPORTED THE FOLLOWING TO (B)(4): DURING THE PROCEDURE THE EQUIPMENT JUST SHUT OFF AND THE DOCTOR HAD TO TURN THE SURGERY INTO AN OPEN SURGERY. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? GENERAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8094289 ↗
• InjurySep 11, 2017Inflation Problem

  FOLLOW UP REPORT #1. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED DEVICE ON 19SEP2017. DEVICE SENT TO (B)(4) MANUFACTURER FOR INVESTIGATION, NO INVESTIGATION RESULTS RECEIVED AS OF 02OCT2017. RWMIC RECEIVED ADDITIONAL INFORMATION FROM FACILITY ON 15SEP2017. THE FOLLOWING BOXES HAVE BEEN UPDATED: PATIENT INFORMATION, DATE/DESCRIPTION OF THIS REPORT, SUSPECT DEVICE (NOT CHANGED, SYSTEM REQUIRED DUE TO MISSING DATA REPORT), INITIAL REPORTER INFORMATION, REPORT TYPE / DATE SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6855240 ↗