MITEK 242025Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10886705029013), received between Aug 20, 2019 and Nov 19, 2025 — classified as 2 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (32 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE SHE_2RSTCK_5.9,30,167CW DEVICE TIP OF THE INSTRUMENT IS SHARP LIKE IT'S BROKEN OFF. ANOTHER 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 23595311 ↗
• MalfunctionOct 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICE HAD AN ARC IN THE OPTIC WHICH WAS NOTICED IN THE LAB. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 23367268 ↗
• MalfunctionOct 15, 2025Mechanical Jam; Mechanical Jam

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT WHILE USING THE OBT_BUTTON_4.0,167CW_MITEK DEVICE AND SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICE, THE OBTURATOR GOT STUCK WHEN PULLING IT IN AND OUT OF THE TROCAR SHEATH. IT WAS REPORTED THAT BOTH DEVICES WERE REPLACED AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE. 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 23279535 ↗
• MalfunctionAug 15, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE SHE_2RSTCK DEVICE HAD A MANDREL THAT WAS DIFFICULT TO INSERT / WOULD GET STUCK IN THE JACKET. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815681 ↗
• MalfunctionJun 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AT THE BEGINNING OF AN UNKNOWN SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICE SHUTTER HAD TO BE FORCED IN AND OUT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE DEFECTIVE DEVICE. 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 22182604 ↗
• MalfunctionJun 9, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THIS IS REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS FOUND THAT TWO OBT-BUTTON-4.0,167CW-MITEK DEVICES WERE STUCK WITHIN TWO SHE-2RSTCK-5.9,30,167CW-MITEK DEVICES AND COULD NOT BE REMOVED. THE PROCEDURE WAS SLIGHTLY DELAYED, THOUGH THE EXACT DURATION OF THE DELAY WAS NOT SPECIFIED. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 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 22167654 ↗
• MalfunctionJun 9, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THIS IS REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS FOUND THAT TWO OBT_BUTTON_4.0,167CW_MITEK DEVICES WERE STUCK WITHIN TWO SHE_2RSTCK_5.9,30,167CW_MITEK DEVICES AND COULD NOT BE REMOVED. THE PROCEDURE WAS SLIGHTLY DELAYED, THOUGH THE EXACT DURATION OF THE DELAY WAS NOT SPECIFIED. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 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 22167636 ↗
• MalfunctionJun 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AT THE START OF AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS FOUND THAT THE SHUTTER ON THE SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICE HAD TO BE FORCED IN AND OUT. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE, AS THE SURGERY WAS COMPLETED USING THE SAME DEVICE. 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 22158179 ↗
• MalfunctionApr 4, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE SHE_2RSTCK_5.9,30,167CW SLEEVE AND THE OBT_BUTTON_4.0,167CW TROCAR DEVICE WERE STUCK TOGETHER AND INTERLOCKED. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773525 ↗
• MalfunctionMar 24, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICE SCOPE DOES NOT FIT DUE TO A SLIGHT DISTORTION OF THE SHEATH. IT WAS UNKNOWN IF THE EVENT OCCURRED DURING SURGERY. THERE WERE NO REPORTS OF DELAY IN THE PROCEDURE REPORTED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. 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 21677007 ↗
• MalfunctionMar 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE THE SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICE THE SHEATH WAS SLIGHTLY WARPED SO THE SCOPE WOULD NOT FIT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WAS NO PATIENT INVOLVEMENT. 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 21663812 ↗
• MalfunctionMar 11, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING SETUP PRIOR TO A SURGICAL PROCEDURE THE SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICE WAS BENT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE OPTICAL DEVICE WAS UNA BLE TO ASSEMBLE, THE DISTAL PART WAS DEFORMED. THERE WAS PATIENT INVOLVEMENT. 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 21573476 ↗
• MalfunctionFeb 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANTERIOR RECONSTRUCTION OF THE CRUCIATE LIGAMENT PROCEDURE, IT WAS DISCOVERED THAT THE SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICE WAS DIFFICULT TO PUT ON AND TAKE OFF. AFTER THE SURGERY, THE OPERATION OF THE DEVICE WAS EVALUATED, AND IT WAS OBSERVED THAT THE INNER AND OUTER TUBES WERE QUITE STIFF WHEN THE BUTTON WAS PRESSED TO DISCONNECT THEM FROM THEIR CONNECTED STATE. THERE WAS NO VISIBLE DAMAGE OR DISTORTION TO THE EXTERIOR OF THE DEVICE. HOWEVER, WHEN ATTEMPTING TO ATTACH THE INNER AND OUTER TUBES, THERE WAS NOTICEABLE RESISTANCE DURING THE FINAL 2 MM OR SO BEFORE THEY CLICKED INTO PLACE. ACCORDING TO THE HOSPITAL STAFF, THE DEVICE HAD STARTED TO STIFFEN RECENTLY. THE SPARE DEVICE WAS EVALUATED, AND IT WORKED AS EXPECTED. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 21412809 ↗
• MalfunctionJan 2, 2025Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE OBT_BUTTON_4.0,167CW_MITEK DEVICE BUTTON WAS HARD TO PULL OUT BECAUSE THE OBTURATOR WAS BENT OR THERE WAS A BLOCKAGE INSIDE THE SHE_2RSTCK_5.9,30,167CW_ MITEK SHEATH DEVICE. 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 21054034 ↗
• MalfunctionDec 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE SHE_2RSTCK_5.9,30,167CW DEVICE HAD THE TROCAR WHICH NO LONGER FIT INTO THE SHIRT. 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 21020608 ↗
• MalfunctionDec 4, 2024Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE OBT_BUTTON_4.0,167CW_MITEK OBTURATOR DEVICE WAS STUCK INSIDE THE SHE_2RSTCK_5.9,30,167CW_ MITEK SHEATH DEVICE BECAUSE THE SHEATH WAS BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER OBSERVED THAT BEFORE THE PROCEDURE IT WAS OBSERVED THAT THE BUTTONS ON THE CAMERA HEAD AC - C-MOUNT DEVICE DID NOT WORK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844852 ↗
• MalfunctionOct 22, 2024Mechanical Jam; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY ON (B)(6) 2024 USING THE SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICE AND THE OBT_BUTTON_4.0,167CW_MITEK DEVICE, IT WAS FOUND THAT THE TROCAR WAS STUCK, AND A NEEDLE DRIVER HAD TO BE USED TO PULL THE TROCAR OUT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THERE WAS A SLIGHT SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20503932 ↗
• MalfunctionSep 25, 2024Crack; Display or Visual Feedback Problem; Crack; Display or Visual Feedback Problem

  IT WAS REPORTED BY AN AFFILIATE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE 2X SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICES WERE BLURRY / CRACKED WHILE USED WITH THE 3X HD COUPLER, C-MOUNT, 20MM DEVICES. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DATE OF EVENT OCCURRED WAS UNKNOWN BUT IT WAS KNOWN TO HAVE OCCURRED EITHER ON 8/23/2024 OR 8/24/2024. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 4 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304946 ↗
• MalfunctionSep 19, 2024Device-Device Incompatibility; Material Deformation; Mechanical Jam; Device-Device Incompatibility; Material Deformation; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE 4580 FMS DUO+ PUMP/SHAVER DEVICE SCOPE SHEATH WAS BENT AND FOUND DIFFICULTY INSERTING ALONG WITH TAKING OUT THE TROCAR FROM THE SHEATH. THERE WASN'T A HUGE DELAY BUT FOUND STRUGGLES WHEN CHANGING PORTALS BECAUSE OF THE DIFFICULTY INSERTING AND TAKING OUT TROCAR. ALMOST AS IF IT WAS GETTING STUCK. THERE WAS NO PATIENT HARM AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258534 ↗
• MalfunctionAug 28, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PRIOR TO AN ARTHROSCOPIC CAPSULAR RELEASE FOR FROZEN SHOULDER THE SHE_2RSTCK_5.9,30,167CW DEVICE WAS BEING USED WHEN TRYING TO USE THE OBTURATOR IN QUESTION IN THE SAME WAY AS USUAL, THE INSERTION OF THE OBTURATOR INTO THE SHEATH IN QUESTION WAS VERY TIGHT AND REQUIRED A LOT OF FORCE. USUALLY IT IS INSERTED AND REMOVED WITHOUT ANY RESISTANCE. THERE WAS NO SURGICAL DELAY OR HARM TO PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084563 ↗
• MalfunctionAug 20, 2024Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE INNER TUBE ON THE SHEATH WITH 2 ROTATING STOPCOCKS COMPATIBLE WITH MITEK LOCK 5.9MM X30 DEG X 167MM DEVICE DID NOT FIT SMOOTHLY INTO THE CANNULA; AND THAT THERE WAS CONSIDERABLE RESISTANCE. ACCORDING TO THE REPORT, THE INNER TUBE WAS COVERED WITH SCRATCHES; AND WAS DIFFICULT TO USE FOR SURGERY. THERE WAS PATIENT INVOLVEMENT. 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 20005069 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE SCOPE SURGICAL PROCEDURE ON (B)(6) 2024 THE 4580 FMS DUO+ PUMP/SHAVER DEVICE RUBBER GASKET ON THE SHEATH BROKE. 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 19911352 ↗
• MalfunctionJul 23, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE SHEATH WITH 2 ROTATING STOPCOCKS COMPATIBLE WITH MITEK LOCK 5.9MM X30 DEG X 167MM DEVICE HAD A SHARP MANDREL STUCK IN THE SHEATH. THERE WAS NO PROCEDURE NOR 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 19806498 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT DURING DEVICE SETUP IT WAS OBSERVED THAT THE SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICE HAD A BROKEN SCOPE SHEATH. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613960 ↗
• MalfunctionMay 1, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  REPORT 1 OF 2 FOR (B)(6) IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC KNEE SCOPE PROCEDURE ON (B)(6) 2024, WITH OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK) DEVICE AND, DUAL STOPCOCK SHEATH 5.9MM X 30 DEG X 167MM (MITEK LOCK) DEVICE WAS GETTING STUCK INSIDE THE SHEATH AND WAS VERY DIFFICULT TO FREE ONCE INSERTED INTO THE SHEATH. 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 19221701 ↗