NA 242048Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886705028108), received between Jul 10, 2019 and Nov 13, 2025 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (15 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING FOR A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HD EPSCP, 1.9, 30, 60, CW_STORZ DEVICE HAD A SCOPE DISPLAY MALFUNCTION. THERE WAS NO REPORT OF PATIENT HARM OR DELAY IN SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542661 ↗
• MalfunctionJun 25, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE HD EPSCP,1.9,30,60,CW_STORZ DEVICE IMAGE QUALITY WAS NOT CLEAR. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330527 ↗
• MalfunctionDec 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE HD EPSCP, 4.0, 70, 167, MITEK DEVICE HAD A POOR IMAGE QUALITY. THE EVENT WAS NOT RELATED TO SURGERY. IT WAS REPORTED THAT THE DEVICE WAS NOT INTENDED FOR HUMAN USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819842 ↗
• MalfunctionNov 8, 2024Crack; Display or Visual Feedback Problem; Crack; Display or Visual Feedback Problem

  IT WAS REPORTED THAT WHILE TWO SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICES AND THREE HD EPSCP,1.9,30,60,CW_STORZ DEVICES WERE IN USE TOGETHER, IT WAS NOTED THAT DEVICES WERE BLURRY (HAD POOR IMAGE) AND WERE CRACKED. THE EVENT OCCURRED DURING A CADAVER LAB. THE EXACT DATE OF EVENT WAS UNKNOWN BUT WAS REPORTED TO HAVE OCCURRED EITHER ON AUGUST 23, 2024 OR AUGUST 24, 2024. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 5 OF 5 OF THE SAME EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640025 ↗
• MalfunctionOct 22, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED FROM SOUTH KOREA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HD EP ARTHROSCOPE/SINUSCOPE DISPLAY DID NOT APPEAR ON THE MONITOR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20508761 ↗
• MalfunctionSep 19, 2024Crack; Display or Visual Feedback Problem; Crack; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 30 DEG, 60MM (STORZ STYLE) DEVICE WAS BLURRY AND CRACKED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256835 ↗
• MalfunctionJun 20, 2024Break; Break

  IT WAS REPORTED THAT DURING CASE SETUP, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 30 DEG, 60MM (STORZ STYLE) DEVICE HAD A BROKEN LENS. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574492 ↗
• MalfunctionMar 14, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE BARS INSIDE THE SCOPE OF THE HD EPSCP,1.9,30,60,CW_STORZ DEVICE WERE DAMAGED AND HAD POOR IMAGE QUALITY, THERE WAS NO LIGHT OUTPUT COMING THROUGH THE SCOPE OF THE 4K C-MNT SCP,4.0,30,167 DEVICE CAUSING BAD IMAGE QUALITY, AND THE COUPLER AC FFL 19 DEVICE WAS NOT HOLDING THE SCOPE CAUSING POOR IMAGE QUALITY. IT WAS NOT REPORTED IF SPARE DEVICES WERE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908560 ↗
• MalfunctionFeb 27, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE BARS INSIDE THE 4K C-MNT SCP,4.0,30,167,MITEK SCOPE WERE DAMAGED AND HAD POOR IMAGE QUALITY. IT WAS FURTHER OBSERVED THAT THE HD EPSCP,1.9,30,60,CW_STORZ SCOPE DEVICE HAD NO LIGHT OUTPUT COMING THROUGH CAUSING BAD IMAGE QUALITY. ALSO, THE COUPLER AC FFL 19 DEVICE WAS NOT HOLDING THE SCOPE CAUSING POOR QUALITY IMAGING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788260 ↗
• MalfunctionDec 7, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING CASE SET UP FOR AN UNKNOWN SURGERY ON (B)(6) 2023, IT WAS OBSERVED THAT THE HD EPSCP,1.9,30,60,CW_STORZ ENDOSCOPE DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281433 ↗
• MalfunctionJun 8, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE LENS ON THE HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 30 DEG, 60MM (STORZ STYLE) DEVICE WERE BROKEN. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17089597 ↗
• MalfunctionJun 1, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE LENS ON THE HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 30 DEG, 60MM (STORZ STYLE) DEVICE WERE BROKEN. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17042468 ↗
• MalfunctionMay 3, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A WRIST DEMONSTRATION, IT WAS OBSERVED THAT TWO (2) HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 30 DEG, 60MM (STORZ STYLE) DEVICES BROKE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863101 ↗
• MalfunctionMay 3, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A WRIST DEMONSTRATION, IT WAS OBSERVED THAT TWO (2) HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 30 DEG, 60MM (STORZ STYLE) DEVICES BROKE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863090 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 30 DEG, 60MM (STORZ STYLE) DEVICE HAD BROKEN LENS. 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 16057304 ↗
• MalfunctionMay 20, 2022Break; Crack; Break; Crack

  IT WAS REPORTED BY SALES REP THAT A HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 30 DEG, 60MM (STORZ STYLE) DEVICE WAS CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE OUTER TUBE DAMAGED, BENT/DENTED, DISTAL TIP WAS DAMAGED, DISTAL TIP FIBER DAMAGED, THE COMPACT OBJECTIVE WAS LOOSE, THE LENSES WERE BROKEN IN THE OPTICAL SYSTEM AND LESS THAN 50% OF LENSES WERE DEFECTIVE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454822 ↗
• MalfunctionNov 9, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT THE HD EPSCP,1.9,0,60,CW_STORZ ENDOSCOPE DEVICE WAS BLACKED OUT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780353 ↗
• MalfunctionOct 21, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT THE HD EPSCP,1.9,30,60,CW_STORZ ENDOSCOPE DEVICE HAD CLOUDY IMAGES AFTER IT WAS PLUGGED INTO A CAMERA AND COUPLER. ACCORDING TO THE REPORT, AN ATTEMPT WAS MADE TO CLEAN THE LENSES BUT DID NOT RESOLVE THE ISSUE OF THE BLURRY IMAGES THAT THE DEVICE PRODUCED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12675295 ↗
• MalfunctionOct 21, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT THE HD EPSCP,1.9,30,60,CW_STORZ ENDOSCOPE DEVICE HAD CLOUDY IMAGES AFTER IT WAS PLUGGED INTO A CAMERA AND COUPLER. ACCORDING TO THE REPORT, AN ATTEMPT WAS MADE TO CLEAN THE LENSES BUT DID NOT RESOLVE THE ISSUE OF THE BLURRY IMAGES THAT THE DEVICE PRODUCED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12675281 ↗
• MalfunctionSep 20, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT UPON INSPECTION OF OPTICS ON THE HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 30 DEG, 60MM (STORZ STYLE) DEVICE, IT WAS OBSERVED THAT IT TOOK A CLOUDY PICTURE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12500715 ↗
• MalfunctionAug 5, 2021Break; Break

  IT WAS REPORTED BY THAT DURING IN-HOUSE RETURN INSPECTION, IT WAS FOUND THAT THE HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 30 DEG, 60MM (STORZ STYLE) ENDOSCOPE DEVICE WAS RETURNED IN TWO PIECES. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283143 ↗
• MalfunctionJul 2, 2021Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  IT WAS REPORTED THAT DURING RETURN INSPECTION, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 30 DEG, 60MM (STORZ STYLE) DEVICE WAS BENT AND HAD A SHADOW IN THE FIELD OF VIEW. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108568 ↗
• MalfunctionMay 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP T DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DEVICE WAS. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT FIBERS BROKEN, ILLUMINATION LOW. OPTICAL SYSTEM, OPTICAL COMPONENTS. BROKEN LENSES IN OPTICAL SYSTEM LESS THAN 50% OF LENSES DEFECTIVE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. AS REPORTED BY THE SALES REP VIA EMAIL, "NO PATIENT CONSEQUENCES FOR THIS COMPLAINT. BENT LENS WHILE IN-SERVICING NOT DURING A CASE" THAT IS ALL THE INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855426 ↗
• MalfunctionApr 1, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING RETURN INSPECTION, IT WAS OBSERVED THAT THE ENDOSCOPE DEVICE WAS CLOUDY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604139 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE HD EPSCP,1.9,30,60,CW_STORZ DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11321150 ↗