MITEK 242258Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10886705029174), received between Oct 6, 2020 and Oct 15, 2025 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (26 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Mechanical Jam; Mechanical Jam

  REPORT 1 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 23279382 ↗
• MalfunctionAug 14, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE OBT_BUTTON_4.0,167CW_MITEK DEVICE HAD A MANDREL THAT WAS DIFFICULT TO INSERT AND GOT STUCK IN THE JACKET. 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 22802012 ↗
• MalfunctionJun 9, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THIS IS REPORT 2 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 22167668 ↗
• MalfunctionJun 9, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THIS IS REPORT 4 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 22167625 ↗
• MalfunctionJun 4, 2025Device-Device Incompatibility; Material Deformation; Scratched Material; Device-Device Incompatibility; Material Deformation; Scratched Material

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY SURGICAL PROCEDURE THE OBT_BUTTON_4.0,167CW_MITEK DEVICE SHEATH WAS BENT AND THE RESPONSIBLE OBRTURATOR WAS DAMAGED (SCRATCHED). IT WAS IMPOSSIBLE TO INSERT THE OBTURATOR INTO THE SHEATH. 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 22143192 ↗
• 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 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773691 ↗
• MalfunctionJan 2, 2025Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  REPORT 2 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 21054035 ↗
• 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 1 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844657 ↗
• MalfunctionOct 22, 2024Mechanical Jam; Mechanical Jam

  THIS IS REPORT 2 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 20503940 ↗
• MalfunctionSep 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT ON 9/11/2024 WHILE USING THE OBT_BUTTON_4.0,167CW_MITEK OBTURATOR DEVICE AND SHE_2RSTCK_5.9,30,167CW_ MITEK SHEATH DEVICE, IT WAS OBSERVED THAT THE DEVICES WERE RUBBING AGAINST EACH OTHER. 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 20299029 ↗
• MalfunctionJul 25, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED, FROM FRANCE. THAT THE BUTTON TOP OBTURATOR DEVICE WAS STUCK IN THE SHEATH DEVICE. IT WAS NOT REPORTED, IF THE DEVICE WAS USED IN SURGERY OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED, IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826643 ↗
• MalfunctionMay 9, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE OBT_BUTTON_4.0,167CW_MITEK DEVICE WAS BENT. IT WAS NOT REPORTED WHEN THE EVENT OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19276789 ↗
• MalfunctionMay 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE OBT_BUTTON_4.0,167CW_MITEK DEVICE WAS BENT. IT WAS NOT REPORTED IF THIS EVENT OCCURRED DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19263986 ↗
• MalfunctionMay 1, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  REPORT 2 OF 2 FOR (B)(4). 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 19221704 ↗
• MalfunctionMar 25, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM FRANCE THAT THE OBT_BUTTON_4.0,167CW DEVICE WAS STUCK IN A CONDUIT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970316 ↗
• MalfunctionMar 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP FROM JAPAN THAT DURING A MENISCECTOMY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT WHEN THE SURGEON ATTEMPTED TO INSERT THE BUTTON TOP OBTURATOR FOR 5.9 MM SHEATH COMPATIBLE WITH MITEK LOCK 167 MM LENGTH DEVICE INTO THE SHEATH, THE OBTURATOR APPEARED TO BE BENT AND THERE WAS RESISTANCE. IT MADE IT DIFFICULT TO INSERT. THERE WERE NO MAJOR PROBLEMS IN USE; HOWEVER, IT WAS DIFFICULT TO USE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. ANOTHER DEVICE WAS USED 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968223 ↗
• MalfunctionFeb 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT BEFORE AN UNKNOWN PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK), DUAL STOPCOCK SHEATH 5.9MM X 30 DEG X 167MM (MITEK LOCK) WAS BENT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 18632982 ↗
• MalfunctionJan 31, 2024Device-Device Incompatibility; Material Deformation; Mechanical Jam; Device-Device Incompatibility; Material Deformation; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT THE DUAL STOPCOCK SHEATH 5.9MM X 30 DEG X 167MM (MITEK LOCK) AND OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK) DEVICES CONTINUED TO GET STUCK TOGETHER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHAFT OF THE DEVICE WAS BENT AT THE MID BODY AND RESISTANCE WAS FELT WHEN TRYING TO ASSEMBLE AND DISASSEMBLE AS THE OBTURATOR WAS ASSEMBLED IN THE SHEATH. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED. REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612390 ↗
• MalfunctionDec 1, 2023Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT PRIOR AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2023 IT WAS OBSERVED THAT THE SHE_2RSTCK_5.9,30,167CW_ MITEK SHEATH DEVICE AND THE OBT_BUTTON_4.0,167CW_MITEK OBTURATOR DEVICE WERE GETTING STUCK, AND WERE BELIEVED TO BE BENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. OTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252077 ↗
• MalfunctionNov 28, 2023Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT ON 11/14/2023, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 30 DEG X 167MM (MITEK LOCK) DEVICE WAS CLOUDY AND THE OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK) DEVICE WAS BENT. IT WAS UNKNOWN WHETHER THE EVENT OCCURRED DURING SURGERY. HOWEVER, IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. 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 18220478 ↗
• MalfunctionNov 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED FROM AN AFFILIATE THAT ON 10/27/2023, IT WAS OBSERVED THAT THE OBT_BUTTON DEVICE SHAFT OF THE TROCAR AND CANNULA WERE BOTH BENT. NO SURGERY IMPACTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075739 ↗
• MalfunctionOct 10, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK) DEVICE AND THE DUAL STOPCOCK SHEATH 5.9MM X 30 DEG X 167MM (MITEK LOCK) DEVICE WERE STICKING TOGETHER. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17907604 ↗
• MalfunctionOct 2, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING STERILE PROCESSING, IT WAS OBSERVED THAT THE OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK) DEVICE WAS BENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856147 ↗
• MalfunctionAug 14, 2023Mechanical Jam; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 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 WERE STICKING WHILE IN USE TOGETHER. 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 17542531 ↗
• MalfunctionAug 3, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT BEFORE STERILIZATION, IT WAS OBSERVED THAT THE OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK) DEVICE WAS DEFORMED. ACCORDING TO THE REPORT, WHEN THE SURGEON TRIED TO INSERT THE OBTURATOR IN QUESTION INTO THE SHEATHE BEFORE STERILIZATION, THERE WAS STRONG RESISTANCE AND IT DID NOT GO IN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452473 ↗