NA 242032Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886705031641), received between Aug 3, 2022 and Sep 17, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Device-Device Incompatibility; Mechanical Jam

  It was reported on (b)(6)2026, that the product was observed shortly after opening the product that the product could not be withdrawn once the obturator was pushed as previously reported ((b)(4)). The button at the connection site also could not return once it was pushed. The product was not used for procedure due to the issue.No further information is available.It was reported that during "[NAME OF SURGERY]" surgery, the SHE_2RSTCK 5.9, UNIV, 167_MITEK sheath and trocar device would not come apart (jammed/seized), also the lock button at the connection site also could not return once it was pushed. 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 50803548 ↗
• MalfunctionSep 3, 2026Break; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595606 ↗
• MalfunctionMay 26, 2026Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE SHEATH 2 RSTCK 5.9,UNIV,167 MITEK DEVICE THE SCOPE GOT STUCK. WHEN SWITCHING PORTALS, THE SURGEON TRIED TO SWITCH TO THE TROCAR, BUT THE SCOPE GOT STUCK IN THE SHEATH. IT DIDN'T FEEL LIKE THE SHAFT WAS BENT AND STUCK, BUT RATHER LIKE THE LOCKING MECHANISM WAS JAMMED AND WOULDN'T COME OFF. ONCE IT CAME OFF, LOCKING AND UNLOCKING WORKED SMOOTHLY WITHOUT ANY PROBLEMS. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. 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 MAY 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25282426 ↗
• MalfunctionMay 11, 2026Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE SHEATH 2 RSTCK 5.9,UNIV,167 MITEK DEVICE THE SCOPE GOT STUCK. WHEN SWITCHING PORTALS, THE SURGEON TRIED TO SWITCH TO THE TROCAR, BUT THE SCOPE GOT STUCK IN THE SHEATH. IT DIDN'T FEEL LIKE THE SHAFT WAS BENT AND STUCK, BUT RATHER LIKE THE LOCKING MECHANISM WAS JAMMED AND WOULDN'T COME OFF. ONCE IT CAME OFF, LOCKING AND UNLOCKING WORKED SMOOTHLY WITHOUT ANY PROBLEMS. 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 25139518 ↗
• MalfunctionApr 9, 2026Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT UPON ATTEMPTING TO USE THE SHEATH AND OBTURATOR DEVICES, THE SURGEON DISCOVERED THAT THE OBTURATOR WAS VERY STIFF AND DIFFICULT TO ATTACH AND DETACH. IT WAS REPORTED THAT IT WAS UNCLEAR WHETHER THE SHEATH OR THE OBTURATOR WAS THE SOURCE OF THE PROBLEM. THERE WERE NO DELAYS TO THE 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 24835189 ↗
• MalfunctionApr 9, 2026Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT UPON ATTEMPTING TO USE THE SHEATH AND OBTURATOR DEVICES, THE SURGEON DISCOVERED THAT THE OBTURATOR WAS VERY STIFF AND DIFFICULT TO ATTACH AND DETACH. IT WAS REPORTED THAT IT WAS UNCLEAR WHETHER THE SHEATH OR THE OBTURATOR WAS THE SOURCE OF THE PROBLEM. THERE WERE NO DELAYS TO THE 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 24835188 ↗
• MalfunctionMar 2, 2026Break; Power Problem

  IT WAS REPORTED THAT DURING EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE SHE_2RSTCK_5.9,UNIV,167_MITEK WAS BROKEN IN 2+PIECES. IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD NOT POWER ON. 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 24485003 ↗
• MalfunctionFeb 26, 2026Leak/Splash

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE SHE_2RSTCK_5.9,UNIV,167_MITEK SHEATH DEVICE WAS LEAKING FLUID. 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 24462356 ↗
• MalfunctionFeb 26, 2026Leak/Splash

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE SHE_2RSTCK_5.9, UNIV,167_MITEK SHEATH DEVICE WAS LEAKING FLUID. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A MINOR 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 24461365 ↗
• MalfunctionFeb 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SHE_2RSTCK_5.9,UNIV,167_MITEK SHEATH DEVICE FELL APART. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING THE SURGICAL PROCEDURE, OR IF THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT THE DEVICE WAS A NEW DEVICE. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402996 ↗
• MalfunctionFeb 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SCOPING PROCEDURE IT WAS OBSERVED THAT THE LOCKING MECHANISM OF THE SHE_2RSTCK_5.9, UNIV,167_MITEK DEVICE WAS NOT WORKING. IT WAS REPORTED THAT THERE WAS A SPARE DEVICE AVAILABLE FOR USE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338630 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT THE WHILE USING THE SHE_2RSTCK_5.9,UNIV,167_MITEK DEVICE, THE SCOPE SHEATH RELEASE BUTTON WAS BROKEN. THERE WAS NO 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24169326 ↗
• MalfunctionDec 30, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ONE SIDE OF THE COCK PART OF THE SHE_2RSTCK_5.9,UNIV,167_MITEK DEVICE WAS EXCESSIVELY STIFF, WITH A NOTICEABLE PROTRUSION. THE REPORTER INDICATED THAT THE ABNORMAL HARDNESS MAY CAUSE INTERFERENCE DURING 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 23921189 ↗
• MalfunctionDec 15, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT ONE OF THE COCKS ON THE SHE_2RSTCK_5.9,UNIV,167 DEVICE WAS VERY STIFF AND FELT LIKE IT WAS GETTING STUCK. THERE WERE NO DELAYS TO THE 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 23804120 ↗
• MalfunctionNov 3, 2025Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING DEVICE TESTING, THE EQUIPMENT MAINTENANCE, IT WAS OBSERVED THAT THE SHE_2RSTCK_5.9,UNIV,167_MITEK DEVICE ORANGE RING BROKE ON THE SCOPE SHEATH AND IS CAUSING THE SHEATH TO LEAK. THIS EVENT DID NOT OCCUR DURING 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 23453490 ↗
• MalfunctionJul 31, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT WHILE USING A SHE_2RSTCK_5.9,UNIV,167_MITEK DEVICE AND 4K EPSCP SCP,4.0,30,167,MITEK DEVICE, IT WAS OBSERVED THAT A BLACK LINE APPEARED ON THE SCOPE AND DID NOT GO AWAY WHEN CLEANED. 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 22673625 ↗
• MalfunctionFeb 12, 2025Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT THE SHE_2RSTCK_5.9,30,167CW MITEK DEVICE DID NOT FUNCTION ALONG WITH X2 CAMERA HEAD AC-C-MOUNT DEVICES, MICRO TORNADO HP W HANDCONTROL DEVICE, SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE AND HD COUPLER, C-MOUNT, 20MM DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT A VALVE WAS JAMMED IN CLOSED POSITION AND IT WAS NOT POSSIBLE TO OPEN THE VALVE. 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 21363118 ↗
• MalfunctionFeb 10, 2025Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE VALVE ON THE SHE_2RSTCK_5.9,UNIV,167_MITEK DEVICE WAS DIFFICULT TO OPEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS JAMMED/SEIZED. THE EVENT WAS NOT RELATED TO SURGERY. IT WAS REPORTED THAT THE DEVICE WAS NOT INTENDED FOR HUMAN USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343397 ↗
• MalfunctionOct 16, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED FROM THE SALES REP THAT PRIOR TO SURGERY, IT WAS OBSERVED THAT THE SHE_2RSTCK_5.9,UNIV,167_MITEK DEVICE DUAL STOP COCK, LOCK HAD AN ISSUE WITH THE SHEATH TO OUR SCOPE. THE FLUID WAS SPRAYING FROM THE SHEATH AS IF IT WERE BROKEN. WE GOT ANOTHER TRAY OPEN, AND THE CASE WAS ABLE TO PROCEED. THERE WAS AN UNSPECIFIED AMOUNT OF SURGICAL DELAY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462614 ↗
• MalfunctionOct 1, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 WHILE USING THE SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICE AND 4K C-MNT SCP,4.0,30,167,MITEK DEVICE, THE SCOPE AND CANNUAL WERE CAUSING ISSUES WITH THE IMAGE QUALITY. 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. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342473 ↗
• 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 ON 8/23/2024 OR 8/24/2024. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS EVENT 2 OF 4 OF THE SAME EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304965 ↗
• MalfunctionSep 17, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED FROM THE SALES REP THAT DURING CLEANING/STERILIZATION PROCESS IT WAS OBSERVED THAT THE SHE_2RSTCK_5.9,UNIV,167_MITEK DEVICE "STOP COCK, MITEK LOCK HAS THE SCREW ON THE STOPCOCK LEAVER ON THE SHEATH BROKE OFF AND AS A RESULT THE STOPCOCK LEAVER HANDLE CAME APART". THIS EVENT DID NOT OCCUR DURING SURGERY. 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 20239998 ↗
• MalfunctionAug 3, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE INFLOW TUBING BROKE OFF; AND HAD A PLASTIC STUCK INSIDE. 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 15157007 ↗