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NA 242009Recalls & reported problems

Medos International Sàrl · HD EP Arthroscope/Sinuscope compatible with Storz style 4.0mm x 70 deg x 175mm · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705028788), received between Mar 3, 2020 and Jun 30, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 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

Device problems

  • Display or Visual Feedback Problem3
  • Scratched Material3
  • Break2
  • Poor Quality Image2
  • Use of Device Problem2
  • Crack1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 30, 2022Break; Use of Device Problem; Break; Use of Device Problem

    IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE HD EP ARTHROSCOPE/SINUSCOPE 4.0MM X 70 DEG X 175MM (STORZ LOCK) DEVICE WAS DROPPED DURING REPROCESSING AND HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BROKEN LENSES IN ITS OPTICAL SYSTEM. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14879806 ↗
  • MalfunctionMar 9, 2022Break; Crack; Scratched Material; Break; Crack; Scratched Material

    IT WAS REPORTED BY THE SALES REP THAT THE DISTAL TIP ON THE HD EPSCP,4.0,70,175,CW_STORZ DEVICE WAS SCRATCHED AND ITS INTERNAL LENS CRACKED IN HALF. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BROKEN LENSES IN THE OPTICAL SYSTEM. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13710951 ↗
  • MalfunctionDec 2, 2021Poor Quality Image; Scratched Material; Poor Quality Image; Scratched Material

    IT WAS REPORTED BY THE CUSTOMER THAT DURING AN ARTHROSCOPIC HIP SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE DISTAL TIP-ON THE HD EPSCP, (B)(4 )STORZ ENDOSCOPE DEVICE CAME IN CONTACT WITH THE SHAVER BLADE THEN SCRATCHING THE DISTAL TIP. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD AN IMAGE ERROR; AND THAT THE IMAGE ON THE CAMERA WAS CLOUDY/BLURRED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12915903 ↗
  • MalfunctionJul 13, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED BY THE SALES REP THAT DURING STERILE PROCESSING FIELD INSPECTION PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE HD EPSCP,4.0,70,175,CW_STORZ DEVICE APPEARED VERY FOGGY WHEN LOOKING THROUGH IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12158993 ↗
  • MalfunctionJul 9, 2021Use of Device Problem; Use of Device Problem

    IT WAS REPORTED BY THE SALES REP THAT DURING HIP PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE DISTAL TIP ON THE HD EPSCP,4.0,70,175,CW_STORZ DEVICE WAS DAMAGED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BROKEN LENSES IN ITS OPTICAL SYSTEM. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12143038 ↗
  • MalfunctionApr 30, 2021Scratched Material; Scratched Material

    IT WAS REPORTED BY THE SALES REP THAT DURING REPROCESSING FOR A HIP PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE DISTAL LENS ON THE ENDOSCOPE DEVICE WAS SCRATCHED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE IMAGE ON THE CAMERA WAS CLOUDY AND BLURRY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11752636 ↗
  • MalfunctionApr 27, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE ENDOSCOPE DEVICE HAD A SHINY ASPECTS IN THE OPTIC. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11733172 ↗
  • MalfunctionFeb 24, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING INSPECTION ON (B)(6) 2020, IT WAS OBSERVED THAT THE LENS ON THE HD EPSCP,4.0,70,175,CW_STORZ DEVICE WAS PHYSICALLY DAMAGED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11373547 ↗
  • MalfunctionMar 3, 2020Poor Quality Image; Poor Quality Image

    IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE HD EPSCP, 4.0, 70 , 175, CW_STORZ HAS STAINS AND SCRATCHES. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9780863 ↗

Other NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) devices

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Sources and updates

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