Endoscope Refurbished MCENDO550RRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00699753023222), received between Jul 12, 2018 and Feb 6, 2024 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2024Misfocusing; Misfocusing

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR A BROKEN SCOPE, AS IT WILL NOT STAY FOCUS. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18654441 ↗
• InjuryMay 9, 2023Optical Problem; Optical Problem

  CLOUDY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897321 ↗
• MalfunctionApr 20, 2023Optical Problem; Optical Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR A BLURRY ENDOSCOPE. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, WHETHER THERE WAS A DELAY IN THE PROCEDURE, WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THERE WAS ANY EFFECT ON THE PATIENT RESULTS OF THE SURGERY. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. AS PER THE USER FACILITY, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16780399 ↗
• InjuryApr 21, 2022Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING, THE LENS BROKE. THEY CAN'T SEE ANY IMAGE THROUGH THE SCOPE. THERE WAS A 45 MINUTES DELAY FOR CONVERTING TO OPEN VEIN SURGERY. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14171564 ↗
• MalfunctionApr 16, 2021Optical Problem; Optical Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE SCOPE WAS BLURRY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 11678657 ↗
• MalfunctionApr 29, 2020Optical Problem; Optical Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR A BLACKED OUT SCOPE. IT IS UNKNOWN IF THERE WAS DELAY, WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: No Information

  MAUDE report 10012170 ↗
• MalfunctionDec 6, 2019Optical Problem; Optical Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ENDOSCOPE WAS BLURRY. THE PRODUCT WAS CHANGED OUT. IT IS UNKNOWN WHETHER THERE WAS BLOOD LOSS, WHETHER THE SURGERY WAS COMPLETED SUCCESSFULLY OR IF THERE WAS ANY PATIENT EFFECT. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9433068 ↗
• MalfunctionDec 6, 2019Break; Break

  NEW INFORMATION RECEIVED THAT THE EVENT OCCURRED DURING SETUP, THE PRODUCT WAS CHANGED OUT, NO DELAY AND PROCEDURE COMPLETED SUCCESSFULLY WITH NO PATIENT EFFECT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 9432904 ↗
• MalfunctionJun 21, 2019Optical Problem; Optical Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE SCOPE WAS FOGGY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. IT IS UNKNOWN IF THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8724092 ↗
• MalfunctionMay 17, 2019Optical Problem; Optical Problem

  NEW INFORMATION WAS RECEIVED INDICATING THAT THE ISSUE OCCURRED DURING VEIN HARVESTING PROCEDURE, THE PRODUCT WAS CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8619415 ↗
• MalfunctionDec 17, 2018Optical Problem; Optical Problem

  THE EVENT OCCURRED DURING SETUP. THE PRODUCT WAS CHANGED OUT. THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED. SUCCESSFULLY WITH NO PATIENT EFFECT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8172299 ↗
• MalfunctionNov 14, 2018Optical Problem; Optical Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE SCOPE WAS BLURRY. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. IT IS UNKNOWN IF THE ISSUE CAUSED A DELAY ON THE PROCEDURE OR IF THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8070080 ↗
• MalfunctionNov 1, 2018Optical Problem; Optical Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE ENDOSCOPE WAS BLURRY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED OR IF THE SURGERY WAS SUCCESSFUL. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8030760 ↗
• MalfunctionOct 23, 2018Optical Problem; Optical Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THE ENDOSCOPE WAS CLOUDY. IT IS STILL UNKNOWN IF THE EVENT RESULTED IN A DELAY IN THE PROCEDURE NOR IF IT CAUSED OR CONTRIBUTED TO AN INJURY TO THE PATIENT. THERE WAS A BLOOD LOSS BUT THE AMOUNT IS YET TO BE DETERMINE. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss

  MAUDE report 7997965 ↗
• InjuryJul 12, 2018Optical Problem; Optical Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THE SCOPE WAS BLURRY. THEY PROCEED WITHOUT THE SCOPE AND CONVERTED TO OPEN VEIN HARVEST. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Injury

  MAUDE report 7683646 ↗
• InjuryJul 12, 2018Optical Problem; Optical Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THE SCOPE WAS BLURRY AS RESULT THEY PROCEED WITHOUT THE SCOPE AND CONVERTED THE PROCEDURE TO OPEN VEIN HARVESTING. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Injury

  MAUDE report 7683633 ↗