NA 242043Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10886705026234), received between Nov 16, 2018 and Oct 22, 2024 — classified as 1 injury, 69 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (45 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Display or Visual Feedback Problem; Scratched Material; Display or Visual Feedback Problem; Scratched Material

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE IT WAS OBSERVED THAT THE ARTHSCO,4/140_30_QIK/STRKR HUB WENT DOWN. IT WAS REPORTED THAT THE DEFECTIVE ARTHROSCOPE HAD SCRATCHES AND THEY COULD NOT SEE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 20508802 ↗
• MalfunctionMay 30, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE LENS ON THE ARTHROSCOPE, 4.0MM, 30 DEG, 175MM (STRYKER STYLE) DEVICE APPEARED FOGGY. 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 17024713 ↗
• MalfunctionApr 26, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ARTHSCO,4/140_30_QIK/STRKR HUB DEVICE HAD A STRAIGHT BLACK LINE IN THE CENTER OF THE SCOPE. 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 14209327 ↗
• MalfunctionMar 23, 2022Display Difficult to Read; Use of Device Problem; Display Difficult to Read; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SHOULDER PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ENDOSCOPE DEVICE WAS DAMAGED BY WAND. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE IMAGE FROM THE DEVICE WAS CLOUDY/FOGGY. 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 13858995 ↗
• MalfunctionMar 3, 2022Poor Quality Image; Use of Device Problem; Poor Quality Image; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE DISTAL LENS ON THE ARTHSCO,4/140_30_QIK/STRKR HUB DEVICE WAS IN CONTACT WITH ARTHROSCOPIC SHAVER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT WINDOW AND OPTICS WERE CLOUDY/FOGGY. 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 13662823 ↗
• MalfunctionJan 24, 2022Break; Poor Quality Image; Use of Device Problem; Break; Poor Quality Image; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE DISTAL TIP ON THE ARTHSCO,4/140_30_QIK/STRKR HUB ENDOSCOPE DEVICE CAME INTO CONTACT WITH THE SHAVER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THERE WERE MINOR SCRATCHES, POOR QUALITY AND DARK IMAGE, DISTAL TIP DAMAGED, BURNT, AND SHAVED DOWN AND WINDOW AND OPTICS WERE DAMAGED AND FIBER RECESSED ON THE DEVICE. 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 13336585 ↗
• MalfunctionDec 2, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE INTERNAL COMPONENTS ON THE ARTHSCO, 4/140_30_QIK/STRKR HUB ENDOSCOPE DEVICE WERE BROKEN; AND THAT IT WAS PITCH BLACK WHEN THE SURGEON LOOKED THROUGH IT. 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 12920482 ↗
• MalfunctionNov 30, 2021Poor Quality Image; Scratched Material; Poor Quality Image; Scratched Material

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ARTHSCO, 4/140_30_QIK/STRKR HUB ENDOSCOPE DEVICE APPEARED TO BE DAMAGED AS THERE WAS A SCRATCH ON ITS LENS. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE IMAGE WAS CLOUD AND FOGGY ON THE DEVICE. 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 12894513 ↗
• MalfunctionOct 5, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THERE WAS A HALF MOON LINE WHEN LOOKING THROUGH THE DISTAL LENS ON THE ARTHSCO,4/140_30_QIK/STRKR HUB DEVICE. 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 12577962 ↗
• MalfunctionSep 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SCOPE ON THE ARTHSCO,4/140_30_QIK/STRKR HUB DEVICE WAS BENT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE IMAGE ON THE DEVICE WAS DARK. 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 12527192 ↗
• MalfunctionSep 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SCOPE ON THE ARTHSCO,4/140_30_QIK/STRKR HUB DEVICE WAS BENT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE IMAGE ON THE DEVICE WAS CLOUDY/FOGGY. 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 12527172 ↗
• MalfunctionSep 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SCOPE ON THE ARTHSCO,4/140_30_QIK/STRKR HUB DEVICE WAS BENT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE IMAGE ON THE DEVICE WAS CLOUDY/FOGGY. 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 12526775 ↗
• MalfunctionSep 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SCOPE ON THE ARTHSCO,4/140_30_QIK/STRKR HUB DEVICE WAS BENT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE IMAGE ON THE DEVICE WAS CLOUDY/FOGGY. 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 12526737 ↗
• MalfunctionAug 12, 2021Scratched Material; Scratched Material

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE DISTAL TIP ON THE ARTHROSCOPE, 4.0MM, 30 DEG, 175MM (STRYKER STYLE) DEVICE CAME IN CONTACT WITH AN ARTHROSCOPIC SHAVER BLADE, SCRATCHING THE LENS. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE IMAGE WAS CLOUDY/FOGGY ON THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313458 ↗
• MalfunctionAug 2, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING REPROCESSING, IT WAS OBSERVED THAT THE ARTHSCO,4/140_30_QIK/STRKR HUB DEVICE WAS EXTREMELY FOGGING-UP WHEN TRYING TO LOOK THROUGH IT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12260623 ↗
• MalfunctionJul 9, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ARTHSCO,4/140_30_QIK/STRKR HUB SCOPE DEVICE HAD DARK SPOTS WHICH DID NOT ALLOW TO SEE CLEARLY. 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 12145453 ↗
• MalfunctionApr 30, 2021Display or Visual Feedback Problem; Use of Device Problem; Material Deformation; Display or Visual Feedback Problem; Use of Device Problem; Material Deformation

  IT WAS REPORTED BY SALES REP THROUGH SERVICE REQUEST THAT THE ARTHSCO,4/140_30_QIK/STRKR HUB DEVICE HAD A BENT/DAMAGED/DENTED DISTAL TIP AND 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 11752712 ↗
• MalfunctionApr 20, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT DURING REPROCESSING, IT WAS NOTED THAT THE DISTAL LENS OF THE ENDOSCOPE DEVICE HAD A DARK FILM ON HALF OF THE INSIDE OF THE LENS. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695294 ↗
• MalfunctionApr 8, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ENDOSCOPE DEVICE HAD A DARK IMAGE ON HALF OF ITS LENS. 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 11634140 ↗
• MalfunctionMar 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE ENDOSCOPE DEVICE WAS BENT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE IMAGE WAS CLOUDY AND FOGGY ON THE DEVICE. 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 11589489 ↗
• MalfunctionMar 17, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THERE WAS A BLACK MARK ON THE LENS ON THE ARTHSCO, 4/140_30_QIK/STRKR HUB ENDOSCOPE DEVICE. 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 11507654 ↗
• MalfunctionFeb 3, 2021Display or Visual Feedback Problem; Scratched Material; Display or Visual Feedback Problem; Scratched Material

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP OF THE ARTHROSCOPE, 4.0MM, 30 DEG, 175MM DEVICE HAD A SCRATCH, A LARGE PIECE MISSING AND A PROMINENT DARK SPOT WHEN LOOKING THROUGH THE EYEPIECE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274208 ↗
• MalfunctionJan 15, 2021Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2020, THE ARTHROSCOPE, 4.0 MM, 30 DEG, 175 MM (STRYKER STYLE) WAS DROPPED. UPON INSPECTION, THE SCOPE SEEMED FOGGY WHEN LOOKING THROUGH IT. 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 11178800 ↗
• MalfunctionDec 18, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE ARTHSCO,4/140 30 QIK/STRKR HUB DEVICE HAD FOGGED AND THEY WERE NOT ABLE TO SEE CLEARLY THROUGH IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO SURGICAL DELAY OR PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11038395 ↗
• MalfunctionDec 15, 2020Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE ENDOSCOPE DEVICE WAS FOUND TO HAVE A CRACK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE IMAGE FROM THE DEVICE WAS CLOUDY/FOGGY. 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 11012973 ↗