NA 242047Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705028092), received between Dec 10, 2018 and Apr 23, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  IT WAS REPORTED THAT DURING STERILIZATION IT WAS OBSERVED THAT THE CAMERA OF THE HD EPSCP, 1.9, 0, 60, CW_STORZ SCOPE DEVICE HAD A BLURRY IMAGE AND WAS BENT. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892018 ↗
• MalfunctionMar 26, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AFTER CLEANING IT WAS OBSERVED THAT THE HD EPSCP DEVICE SCOPE WAS BLACK INSIDE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979564 ↗
• MalfunctionDec 27, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY AN AFFILIATE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE HD EPSCP DEVICE HAD A DARK SPOT IN THE CORNER. 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 18398851 ↗
• MalfunctionApr 13, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT A DUAL STOPCOCK SHEATH 5.9MM X 70 DEG X 167MM (MITEK LOCK) ENDOSCOPE DEVICE HAD A CHARRED AND BLACKED OUT POOR VISUALIZATION. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14105225 ↗
• 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 12780341 ↗
• MalfunctionJun 9, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THAT DURING RETURN INSPECTION, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/ SINUSCOPE, EP, 1.9MM, 0 DEG, 60MM (STORZ STYLE) DEVICE HAD CLOUDY 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 11970267 ↗
• MalfunctionJun 9, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THAT DURING RETURN INSPECTION, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/SINUSCOPE, EP, 1.9MM, 0 DEG, 60MM (STORZ STYLE) DEVICE HAD CLOUDY 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 11970221 ↗
• MalfunctionAug 28, 2020Break; Break

  IT WAS REPORTED BY THE EMPLOYEE VIA PHONE THEY NOTICED THAT BOTH HD SCOPES WERE BENT WHEN THEY WERE GOING THROUGH A QUALITY CHECK. THERE WAS NO CASE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10464710 ↗
• MalfunctionJun 21, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY AN EMPLOYEE VIA PHONE THAT WHILE INSPECTING RETURNS, TWO OF THE HD ARTHROSCOPE/SINUSCOPE WERE BENT WHERE THE LENS COMES OUT. THE EMPLOYEE STATED THAT ONE IS BENT AT A NINETY DEGREE ANGLE. THE EMPLOYEE DID NOT KNOW HOW THESE DEVICES BECAME BENT. THERE WAS NO CASE INVOLVED, THEREFORE NO PATIENT INVOLVEMENT OR DELAY. THE DEVICES ARE BEING RETURNED.

  Patient problems: No Patient Involvement

  MAUDE report 8724375 ↗
• MalfunctionJun 21, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY AN EMPLOYEE VIA PHONE THAT WHILE INSPECTING RETURNS, TWO OF THE HD ARTHROSCOPE/SINUSCOPE WERE BENT WHERE THE LENS COMES OUT. THE EMPLOYEE STATED THAT ONE IS BENT AT A NINETY DEGREE ANGLE. THE EMPLOYEE DID NOT KNOW HOW THESE DEVICES BECAME BENT. THERE WAS NO CASE INVOLVED, THEREFORE NO PATIENT INVOLVEMENT OR DELAY. THE DEVICES ARE BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724291 ↗
• MalfunctionDec 10, 2018Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY A J&J EMPLOYEE THAT WHILE CHECKING THE DEVICE, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/SINUSCOPE DEVICE HAD A DENT ON THE OUTSIDE OF THE SCOPE'S TIP. THE J&J EMPLOYEE STATED THAT THE IMAGE WAS FOGGY. THERE WAS NO CASE INVOLVED, THEREFORE NO PATIENT INVOLVEMENT OR DELAY. THE DEVICE IS BEING RETURNED FOR EVALUATION. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 8147736 ↗