Endoscope 5.5 MM Sterile, Reusable MCENDO550Recalls & reported problems
Terumo Cardiovascular Systems Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Terumo 5.5 mm reusable endoscope is used to view and harvest veins during surgery. Most of the 55 reports describe the view going blurry or cloudy mid-procedure, sometimes ending with the surgery converted to an open method, along with a few cracks and lens fogging. Four injuries and no deaths are reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00699753018952), received between Nov 29, 2018 and Jan 17, 2025 — classified as 4 injuries, 51 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (44 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.
Reports received per month
Most reported problems
Device problems
- Optical Problem44
- Crack4
- Fogging4
- Defective Device2
- Break1
- Contamination /Decontamination Problem1
- Insufficient Device Problem Information1
- Material Too Rigid or Stiff1
Patient problems
- Insufficient Information29
- No Clinical Signs, Symptoms or Conditions17
- No Information12
- No Patient Involvement5
- No Known Impact Or Consequence To Patient3
- Injury2
- Blood Loss1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2025Poor Quality Image; Poor Quality Image
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING THERE WAS A BLURRY IMAGE. AS PER THE SUBSIDIARY, A VISUAL INSPECTION IS DONE BEFORE THE DISSECTION. USER CAN SEE THE IMAGE CLEARLY AND START THE PROCEDURE. THE PROCEDURE RUN SMOOTHLY BUT TOWARDS THE END OF DISSECTION, SUDDENLY THE IMAGE TURN BLUR SLOWLY. THEY TAKE OUT THE ENDOSCOPE AND WIPE THE LENS BUT STILL BLURRY. THEY CONVERT TO OPEN METHOD FOR THE VEIN HARVESTING. *NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT *THERE WAS A 30 MINUTES DELAY *PRODUCT WAS NOT CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21180069 ↗MalfunctionFeb 27, 2024Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE SCOPE WAS BLURRING DURING PREPARATION. 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. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.
Patient problems: Insufficient Information
MAUDE report 18791532 ↗MalfunctionFeb 27, 2024Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR A BLURRY SCOPE. 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 PATIENTS, 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 18791516 ↗MalfunctionJan 12, 2024Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR A CLOUDY SCOPE. 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.
Patient problems: Insufficient Information
MAUDE report 18504751 ↗MalfunctionJan 12, 2024Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR A CLOUDY SCOPE. 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.
Patient problems: Insufficient Information
MAUDE report 18504380 ↗MalfunctionJan 12, 2024Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR A CLOUDY SCOPE. 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.
Patient problems: Insufficient Information
MAUDE report 18503925 ↗MalfunctionDec 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THERE WAS AN ISSUE WITH THE ENDOSCOPE. 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. *AS PER THE SUBSIDIARY, THERE WOULD BE NO ADDITIONAL INFORMATION TO BE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 18379103 ↗MalfunctionNov 3, 2023Optical Problem; Optical Problem
InjuryOct 13, 2023Optical Problem; Optical Problem
MalfunctionJun 30, 2023Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE ENDOSCOPE WAS BLURRY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, AND IF THE SURGERY 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. THERE WAS NO DELAY IN THE PROCEDURE, THE PRODUCT WAS CHANGED OUT WITH NO HARM AND NO BLOOD LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17237744 ↗MalfunctionJun 16, 2023Optical Problem; Optical Problem
MalfunctionApr 24, 2023Fogging; Fogging
MalfunctionApr 24, 2023Fogging; Fogging
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE SCOPE WAS HAZY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, IF THERE WAS A DELAY IN THE PROCEDURE, 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 16799449 ↗MalfunctionJan 18, 2023Optical 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 16194858 ↗MalfunctionJan 12, 2023Optical Problem; Optical Problem
AS PER THE USER FACILITY, THE YELLOWISH COLOR WAS NOTICED DURING THE STERILE PROCESSING.
Patient problems: Insufficient Information
MAUDE report 16147006 ↗InjuryOct 13, 2022Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING, NOTICED A BLURRY 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 15597572 ↗MalfunctionOct 3, 2022Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THERE WAS A SCOPE ISSUE. 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 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 15533017 ↗MalfunctionAug 4, 2022Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE SCOPE WAS BLURRY. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. AS PER THE BIOMED, NO FURTHER DETAILS WILL BE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 15163106 ↗MalfunctionJul 15, 2022Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE SCOPE WAS CLOUDY. 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 15029783 ↗MalfunctionMay 18, 2022Crack; Crack
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THE SCOPE HAD A SMUDGE OR CRACK IN THE SCOPE. IT IS UNKNOWN WHETHER THERE WAS A DELAY IN THE PROCEDURE. DUE TO THE UNKNOWN INFORMATION, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14427050 ↗MalfunctionMay 7, 2022Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE LENS HAS A YELLOWISH TINT. IT IS STILL UNKNOWN WHEN THE EVENT OCCURRED, IF IT RESULTED IN A DELAY IN THE PROCEDURE, IF THE PRODUCT WAS CHANGED OUT, IF THE SURGERY WAS COMPLETED SUCCESSFULLY, OR IF IT CAUSED OR CONTRIBUTED TO AN INJURY TO THE PATIENT OR IF THERE WAS A BLOOD LOSS. TERUMO CONTINUES AN ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.
Patient problems: Insufficient Information
MAUDE report 14321671 ↗MalfunctionApr 8, 2022Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THEY NOTICED A FOGGY SCOPE. IT IS UNKNOWN IF THE PRODUCT MALFUNCTION CAUSED OR CONTRIBUTED TO AN INJURY. TERUMO CONTINUES AN ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 2 MINUTES DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14058255 ↗MalfunctionMar 31, 2022Fogging; Fogging
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE LENS WAS FOGGY. 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 13966827 ↗MalfunctionMar 19, 2022Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE SCOPE WAS FOGGY. 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 13827727 ↗MalfunctionMar 14, 2022Optical Problem; Optical Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR AN OBSTRUCTED VIEW. IT IS STILL UNKNOWN WHEN THE EVENT OCCURRED, IF IT RESULTED IN A DELAY IN THE PROCEDURE, IF THE PRODUCT WAS CHANGED OR IF THE SURGERY WAS COMPLETED SUCCESSFULLY OR IF IT CAUSED OR CONTRIBUTED TO AN INJURY TO THE PATIENT OR IF THERE WAS A BLOOD LOSS. TERUMO CONTINUES AN ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.
Patient problems: Insufficient Information
MAUDE report 13763342 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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