NA 242005Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886705028764), received between Jan 22, 2024 and Apr 12, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HD EPSCP,4.0,0,175,CW_STORZ SCOPE WAS NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE OPTICS OF THE SCOPE PARTICULATE UNDER THE DISTAL LENS, AND PARTICULATE UNDER THE PROXIMAL LENS. ALSO, THE LENS WAS BROKEN IN THE OPTICAL SYSTEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101514 ↗
• MalfunctionApr 12, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HD EPSCP,4.0,0,175,CW_STORZ SCOPE WAS NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE OPTICS OF THE SCOPE PARTICULATE UNDER THE DISTAL LENS, AND PARTICULATE UNDER THE PROXIMAL LENS. ALSO, THE LENS WAS BROKEN IN THE OPTICAL SYSTEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101505 ↗
• MalfunctionApr 10, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HD EPSCP,4.0,0,175,CW_STORZ SCOPE WAS NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE OPTICS OF THE SCOPE PARTICULATE UNDER THE DISTAL LENS, AND PARTICULATE UNDER THE PROXIMAL LENS. ALSO, THE LENS WAS BROKEN IN THE OPTICAL SYSTEM, A COSMETIC ISSUE WITH RUST/DISCOLORATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084186 ↗
• MalfunctionApr 10, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HD EPSCP,4.0,0,175,CW_STORZ SCOPE WAS NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE OPTICS OF THE SCOPE PARTICULATE UNDER THE DISTAL LENS, AND PARTICULATE UNDER THE PROXIMAL LENS. ALSO, THE LENS WAS BROKEN IN THE OPTICAL SYSTEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084056 ↗
• MalfunctionApr 10, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HD EPSCP,4.0,0,175,CW_STORZ SCOPE WAS NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE OPTICS OF THE SCOPE PARTICULATE UNDER THE DISTAL LENS, AND PARTICULATE UNDER THE PROXIMAL LENS. ALSO, THE LENS WAS BROKEN IN THE OPTICAL SYSTEM DISTAL COVER GLASS/NEGATIVE DAMAGED SCRATCHES/RESIDUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084030 ↗
• MalfunctionApr 10, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HD EPSCP,4.0,0,175,CW_STORZ SCOPE WAS NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE OPTICS OF THE SCOPE PARTICULATE UNDER THE DISTAL LENS, AND PARTICULATE UNDER THE PROXIMAL LENS. ALSO, THE LENS WAS BROKEN IN THE OPTICAL SYSTEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083975 ↗
• MalfunctionApr 10, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HD EPSCP,4.0,0,175,CW_STORZ SCOPE WAS NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE OPTICS OF THE SCOPE PARTICULATE UNDER THE DISTAL LENS, AND PARTICULATE UNDER THE PROXIMAL LENS. ALSO, THE LENS WAS BROKEN IN THE OPTICAL SYSTEM, AND THERE WAS A COSMETIC ISSUE WITH RUST/DISCOLORATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083901 ↗
• MalfunctionApr 10, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HD EPSCP,4.0,0,175,CW_STORZ SCOPE WAS NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE LENSES WERE BROKEN IN THE OPTICAL SYSTEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083833 ↗
• MalfunctionApr 10, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HD EPSCP,4.0,0,175,CW_STORZ SCOPE WAS NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE OPTICS OF THE SCOPE PARTICULATE UNDER THE DISTAL LENS, AND PARTICULATE UNDER THE PROXIMAL LENS. ALSO, THE LENS WAS BROKEN IN THE OPTICAL SYSTEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083782 ↗
• MalfunctionApr 9, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Material Deformation; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Material Deformation

  THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A CADAVERIC TRAINING EVENT, IT WAS DISCOVERED THAT FIVE HD EP ARTHROSCOPE/SINUSCOPE COMPATIBLE WITH STORZ STYLE 4.0MM X 0 DEG X 175MM DEVICES WERE NOT WORKING UPON ATTEMPTED USE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT ONE OF THE DEVICES HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION AND WAS DEVICE FRACTURED. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICES WERE USED EXCLUSIVELY ON CADAVERS. THERE WERE NO REPORTS OF USER 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075665 ↗
• MalfunctionApr 9, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Material Deformation; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Material Deformation

  THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A CADAVERIC TRAINING EVENT, IT WAS DISCOVERED THAT FIVE HD EP ARTHROSCOPE/SINUSCOPE COMPATIBLE WITH STORZ STYLE 4.0MM X 0 DEG X 175MM DEVICES WERE NOT WORKING UPON ATTEMPTED USE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT ONE OF THE DEVICES HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION AND WAS DEVICE FRACTURED. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICES WERE USED EXCLUSIVELY ON CADAVERS. THERE WERE NO REPORTS OF USER 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075657 ↗
• MalfunctionApr 9, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Material Deformation; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Material Deformation

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A CADAVERIC TRAINING EVENT, IT WAS DISCOVERED THAT FIVE HD EP ARTHROSCOPE/SINUSCOPE COMPATIBLE WITH STORZ STYLE 4.0MM X 0 DEG X 175MM DEVICES WERE NOT WORKING UPON ATTEMPTED USE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT ONE OF THE DEVICES HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION AND WAS DEVICE FRACTURED. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICES WERE USED EXCLUSIVELY ON CADAVERS. THERE WERE NO REPORTS OF USER 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075654 ↗
• MalfunctionApr 9, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Material Deformation; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Material Deformation

  THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A CADAVERIC TRAINING EVENT, IT WAS DISCOVERED THAT FIVE HD EP ARTHROSCOPE/SINUSCOPE COMPATIBLE WITH STORZ STYLE 4.0MM X 0 DEG X 175MM DEVICES WERE NOT WORKING UPON ATTEMPTED USE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT ONE OF THE DEVICES HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION AND WAS DEVICE FRACTURED. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICES WERE USED EXCLUSIVELY ON CADAVERS. THERE WERE NO REPORTS OF USER 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075645 ↗
• MalfunctionApr 9, 2024Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Material Deformation; Break; Use of Device Problem; Device Contaminated During Manufacture or Shipping; Material Deformation

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A CADAVERIC TRAINING EVENT, IT WAS DISCOVERED THAT FIVE HD EP ARTHROSCOPE/SINUSCOPE COMPATIBLE WITH STORZ STYLE 4.0MM X 0 DEG X 175MM DEVICES WERE NOT WORKING UPON ATTEMPTED USE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT ONE OF THE DEVICES HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION AND WAS DEVICE FRACTURED. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICES WERE USED EXCLUSIVELY ON CADAVERS. THERE WERE NO REPORTS OF USER 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075644 ↗
• MalfunctionJan 22, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE J&J EMPLOYEE THAT DURING A LARGE TRAINING EVENT FOR AN ENDOSCOPIC SINUS SURGERY ON (B)(6) 2023, IT WAS DISCOVERED THAT 3 OF THE HD EP ARTHROSCOPE/SINUSCOPE COMPATIBLE WITH STORZ STYLE 4.0MM X 0 DEG X 175MM DEVICES WERE NOT WORKING PROPERLY. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT ONE OF THE DEVICES WAS FRACTURED. THE DEVICES WERE NOT FOR HUMAN USE, THEREFORE THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552075 ↗