NA 2232644Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04055207056462), received between Sep 11, 2017 and Jul 24, 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.

• MalfunctionJul 24, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED: AFTER ABOUT 30 MINUTES DURING THE FIRST CASE THE PUMP WOULD QUIT WORKING AND THE UNIT WOULD BEEP. I HAD TO OPEN THE TRAP DOOR AND CLOSE IT TO MAKE THE BEEPING GO AWAY. THEN I WOULD PRESS THE TEM PUMP BUTTON AGAIN TO GET IT TO WORK. THIS WAS A TEMPORARY FIX SINCE IT KEPT FAULTING MORE OFTEN. IT BECAME SO BAD THAT MY TRICK DIDN'T WORK ANYMORE AND I HAD TO SET UP THE LOANER. 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 PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10321025 ↗
• MalfunctionFeb 7, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON (B)(6) 2020, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED THE FOLLOWING INFORMATION: FIRST TIME THE CUSTOMER HAS USED BOTH ITEMS SINCE THEY CAME IN FOR REPAIR IN (B)(6) 2019. DURING THE PROCEDURE, PUMP STOPPED WORKING AND ERROR CODE E37 SHOWED UP ON SCREEN AND THEN THE RED TRIANGLE STARTED TO FLASH. PROCEDURE WAS STILL BEING DONE WHEN CUSTOMER CALLED THIS IN, BUT IT WAS LATER LEARNED THAT THE PROCEDURE WAS NOT COMPLETED DUE TO THE ITEM GOING DOWN. A BACK UP DEVICE WAS NOT AVAILABLE FOR USE. THERE WAS NO INJURY TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9682543 ↗
• MalfunctionMar 11, 2019Power Problem; Power Problem

  ON (B)(6) 2018, (B)(4) RECEIVED MEDWATCH REPORT # (B)(4). THE FOLLOWING WAS REPORTED: "PATIENT SCHEDULED FOR A TRANSANAL ENDOSCOPIC MICROSURGICAL EXCISION OF THE RECTAL TUMOR USING THE (B)(4) 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 TROUBLESHOOTING THE PROBLEM WITH NO LUCK GETTING THE BOTTOM UNIT TO TURN ON. THE (B)(4) REP, AND TEAM LEADER WAS CALLED TO HELP TROUBLESHOOTING. 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 8407944 ↗
• MalfunctionNov 21, 2018Unexpected Shutdown; Unexpected Shutdown

  ON (B)(6) 2018, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS (RWMIC): 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 8094291 ↗
• InjurySep 11, 2017Inflation Problem

  FOLLOW UP #2 - MANUFACTURER INVESTIGATION RESULTS.

  Patient problems: No Information

  MAUDE report 6855237 ↗