NA 242137Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10886705031993), received between Mar 9, 2022 and May 7, 2026 — classified as 95 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (77 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 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4K EPSCP SCP,4.0,30,167,MITEK DEVICE LENS WAS CRACKED. THERE WERE NO REPORTS OF DELAY TO A PROCEDURE. 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 25117333 ↗
• MalfunctionMay 4, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4K EPSCP SCP,4.0,30,167,MITEK SCOPE DEVICE WAS CRACKED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT THIS WAS AN OUT OF BOX (OOB) CASE. DURING IN-HOUSE ENGINEERING EVALUATION, AFTER INSPECTION OF A RETURNED PHOTO, IT WAS DETERMINED THAT THE SCOPE LENSES HAD A WHITE LINE VISIBLE IN THE ARTHROSCOPIC SPACE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071432 ↗
• MalfunctionMay 1, 2026Break; Scratched Material

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE 4K EPSCP SCP,4.0,30,167 DEVICE WAS BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD A SCRATCHED LENS. 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 25058948 ↗
• MalfunctionApr 30, 2026Crack; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE 4K EPSCP SCP,4.0,30,167,MITEK SCOPE DEVICE WAS CRACKED AFFECTING THE IMAGE DISPLAY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049894 ↗
• MalfunctionApr 28, 2026Crack

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE 4K EPSCP SCP,4.0,30,167,MITEK DEVICE WAS BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE LENS WAS CRACKED/FRAYED DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF DELAYS TO 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 25021313 ↗
• MalfunctionApr 24, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE 4K EPSCP SCP,4.0,30,167 DEVICE WAS DEFECTIVE (DARK DISPLAY). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982223 ↗
• MalfunctionApr 23, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE 4K EPSCP SCP,4.0,30,167,MITEK SCOPE DEVICE WAS EXTREMELY CLOUDY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974354 ↗
• MalfunctionApr 16, 2026Display or Visual Feedback Problem; Scratched Material

  IT WAS REPORTED THAT DURING THE UNKNOWN SURGERY, THE 4K EPSCP SCP,4.0,30,167, MITEK WAS SCRATCHED AND HAD A BIG BLACK MARK IN THE MIDDLE. THE PATIENT WAS UNDER, BUT THE SURGEON WAS NOT IN THE ROOM. THEY STILL USED THE CAMERA WITHOUT ANY DELAYS. NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION WERE NOTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904898 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE USE OF AN ARTHROSCOPE, THE LENS WAS FOUND TO BE BROKEN/RUPTURED. THIS DAMAGE WAS CONFIRMED BOTH ON THE SCREEN AND PHYSICALLY. THE SPECIALIST PERFORMING THE SURGERY DID NOT EXPERIENCE ANY DISCOMFORT OR DIFFICULTY. THE PROCEDURE CONTINUED WITHOUT INTERRUPTION, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT AFFECTED BY THE EVENT, AND THERE WERE NO CHANGES TO THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845680 ↗
• MalfunctionApr 3, 2026Crack; Material Fragmentation

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE 4K EPSCP SCP,4.0,30,167,MITEK DEVICE WAS BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE LENS APPEARED TO BE CRACKED DURING STERILE PROCESSING. THERE WERE NO REPORTS OF DELAYS TO 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 24780855 ↗
• MalfunctionApr 3, 2026Crack

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE 4K EPSCP SCP,4.0,30,16 7,MITEK DEVICE WAS BROKEN (2+ PIECES): CHIPPED/SHAVED/DELAMINATED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE LENS APPEARED TO BE CRACKED DURING STERILE PROCESSING. THERE WERE NO REPORTS OF DELAYS TO 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 24774800 ↗
• MalfunctionMar 16, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE 4K EPSCP SCP,4.0,30,167,MITEK DEVICE WAS FRACTURED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS CRACKED DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF DELAYS TO 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 24607601 ↗
• MalfunctionFeb 24, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT AFTER SURGERY THE 4K EPSCP SCP,4.0,30,167,MITEK DEVICE OPTICS PRODUCED A BLURRY VIEW. THERE WERE NO DELAYS TO SURGERY. 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 24433682 ↗
• MalfunctionFeb 9, 2026Crack; Poor Quality Image

  IT WAS REPORTED THAT DURING EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE 4K C-MNT SCP,4.0,30,167, MITEK DEVICE HAD POOR IMAGE QUALITY. IT WAS INITIALLY REPORTED THAT THE DEVICE HAD A CRACK IN THE MIRROR AT THE TIP OF THE DEVICE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298496 ↗
• MalfunctionFeb 5, 2026Break; Scratched Material

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4K C-MNT SCP, 4.0, 30, 167, MITEK SCOPE DEVICE WAS CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES: CHIPPED/SHAVED/DELAMINATED). THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273396 ↗
• MalfunctionFeb 5, 2026Break; Scratched Material

  IT WAS REPORTED THAT DURING EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE 4K C-MNT SCP,4.0,30,167,MITEK WAS BROKEN IN 2+PIECES. IT WAS INITIALLY REPORTED THAT THE DEVICE HAD A SCRATCH ON THE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270803 ↗
• MalfunctionJan 26, 2026Crack; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE 4K EPSCP SCP,4.0,30,167,MITEK DEVICE HAD POOR IMAGE QUALITY. IT WAS INITIALLY REPORTED THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE, A CRACK-LIKE PHENOMENON WAS OBSERVED IN THE FIELD OF VIEW OF THE CAMERA. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178059 ↗
• MalfunctionJan 7, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY, THE 4K EPSCP SCP,4.0,30,167,MITEK DEVICE HAD POOR SEALING OF THE SEALING RING CAUSES FOGGING OF THE LENS, AFFECTING THE SURGICAL FIELD OF VIEW. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988516 ↗
• MalfunctionJan 6, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT BEFORE AN ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE LENS ON THE 4K EPSCP SCP,4.0,30,167, MITEK DEVICE WAS BLURRED, AND THE IMAGE QUALITY WAS POOR. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 23981671 ↗
• MalfunctionDec 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4K EPSCP SCP,4.0,30,167,MITEK DEVICE HAD A POOR IMAGE. THE LENS WAS BLURRED AND THE IMAGING QUALITY WAS POOR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878408 ↗
• MalfunctionDec 22, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, IT WAS OBSERVED THAT THE 4K EPSCP SCP,4.0,30,167,MITEK DEVICE LENS WAS BLURRED AND THE IMAGING QUALITY WAS POOR. 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 23862432 ↗
• MalfunctionDec 13, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4K EPSCP SCP,4.0,30,167,MITEK SCOPE DEVICE WAS CLOUDY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23797770 ↗
• MalfunctionDec 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY PROCEDURE IT WAS OBSERVED THAT THE 4K EPSCP SCP,4.0,30,167,MITEK ARTHROSCOPE LENS WAS BLURRED, AND THE IMAGING QUALITY WAS POOR. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778903 ↗
• MalfunctionDec 5, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE 4K EPSCP SCP,4.0,30,167,MITEK DEVICE HALOS WERE FOUND IN THE VISUAL FIELD. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727014 ↗
• MalfunctionNov 24, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, IT WAS OBSERVED THAT THE 4K EPSCP SCP,4.0,30,167,MITEK DEVICE LENS WAS DARK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE 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 23631802 ↗