NA 214113Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886705003549), received between Jan 29, 2019 and Jul 17, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE 7.0 X 75MM REUSABLE OBTURATOR -NS DEVICE HAD A HOLE IN THE RUBBER COATING AND IS DETERIORATING. DURING AN IN HOUSE ENGINEERING EVALUATION OF A RETURNED PHOTO IT WAS FOUND THAT THE DEVICE WAS CRACKED/HAD A HOLE IN IT. 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 22532863 ↗
• MalfunctionSep 19, 2024Crack; Crack

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING STERILE PROCESSING, IT WAS OBSERVED THAT THE RUBBER ON THE 7.0 X 75MM REUSABLE OBTURATOR -NS DEVICE AND 8.5 X 75MM REUSABLE OBTURATOR -NS DEVICE WAS PEELING AND EXHIBITED SPLITS. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO 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 20256416 ↗
• MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT TWO PURPLE CANNULA 7.0 X 75MM REUSABLE OBTURATOR DEVICES HAD THEIR METAL INSERT COME OFF WHILE INSERTING CANNULAS. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY REPORTED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915297 ↗
• MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT TWO PURPLE CANNULA 7.0 X 75MM REUSABLE OBTURATOR DEVICES HAD THEIR METAL INSERT COME OFF WHILE INSERTING CANNULAS. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY REPORTED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915200 ↗
• MalfunctionJun 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE REUSABLE OBTURATOR 7.0 X 75MM DEVICE WAS CONTAMINATED UPON INSPECTION. 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 17128487 ↗
• MalfunctionJun 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE REUSABLE OBTURATOR 7.0 X 75MM DEVICE BENT IN MULTIPLE TIMES. 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 17059684 ↗
• MalfunctionDec 6, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT BEFORE STERILIZATION, IT WAS OBSERVED THAT THE REUSABLE OBTURATOR 7.0 X 75MM WAS BROKEN IN TWO PIECES. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15927652 ↗
• MalfunctionMar 8, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 7.0 X 75MM REUSABLE OBTURATOR -NS DEVICE WAS BENT. 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 13695195 ↗
• MalfunctionAug 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA PHONE THAT THE INSERTER HANDLE OF A REUSABLE OBTURATOR 7.0 X 75MM HAS COME PART. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379296 ↗
• MalfunctionNov 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING KIT INSPECTION THE 7.0 X 75MM REUSABLE OBTURATOR NS FELL OUT OF THE HANDLE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9312824 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA CST THAT PRIOR TO A SHOULDER REPAIR PROCEDURE THE 7X75MM REUSABLE OBTURATOR (LOT: 1111001) WAS BROKEN. THE DEVICE IS BROKEN AT THE SHAFT, IT NO LONGER CAN ATTACH TO THE HANDLE. THE SALES REP STATED THE DEVICE WAS NOT USED ON THE PATIENT. ITEM WAS USED TO INSERT A CANNULA AND IT BROKE DURING A PAST SHOULDER ARTHROSCOPY CASE, NO PATIENT WAS HARMED. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM. THERE WAS 5-MINUTE DELAY, HAD TO FIND ANOTHER OBTURATOR. THE DEVICE IS BEING RETURNED FOR EVALUATION. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: Not Applicable

  MAUDE report 9124583 ↗
• MalfunctionAug 7, 2019Break; Break

  ADDITIONAL INFORMATION PROVIDED THE AFFILIATE REPORTED THE PROCEDURE WAS COMPLETED WITH A DISPOSABLE INSERTER.THE AFFILIATE ALSO REPORTED THE LOT NUMBER IS UNKNOWN AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8871826 ↗
• MalfunctionFeb 19, 2019Break; Break

  THE AFFILIATE REPORTED NUM CALLED REP TO REPORT BROKEN INSTRUMENTS. REP NOT PRESENT IN THE CASE SO THERE ARE NO DETAILS ABOUT HOW THE INSTRUMENTS WERE BROKEN. NO REPORTED ADVERSE EVENT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8350924 ↗
• MalfunctionJan 29, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE CUSTOMER'S RE-USABLE OBTURATOR BROKE WHILE IT WAS INSIDE THE CANNULA. THE SURGEON PULLED IT OUT WITH HIS HANDS AND OPENED ANOTHER KIT TO USE ANOTHER SAME LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THIS DELAYED THE PROCEDURE 10 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 8286172 ↗