NA 242085Recalls & reported problems
Medos International Sàrl · Button Obturator Compatible with 2.7 mm Endoscopic System, Mitek Lock · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705031856), received between Mar 15, 2023 and Mar 25, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE PICTURE OF THE HD C-MNT SCP,2.7,30,75,MITEK SCOPE WAS FUZZY, AND THE OBT_BUTTON_2.7,75_MITEK DEVICE WAS BENT AND THE SHE_2RSTCK_3.8,UNIV,75_MITEK SHEATH WAS BENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE 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 18968425 ↗MalfunctionMar 15, 2023Material Deformation; Material Deformation
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT DURING AN ANKLE SCOPE PROCEDURE ON (B)(6) 2023, THE SURGEON BENT A BUTTON OBTURATOR COMPATIBLE WITH 1.9 MM ENDOSCOPIC SYSTEM AND A BUTTON OBTURATOR COMPATIBLE WITH 2.7 MM ENDOSCOPIC SYSTEM. ACCORDING TO THE REPORT, THE DEVICES BENT ACCESSING THE JOINT IN A VERY TIGHT ANKLE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICES. 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 16548609 ↗
Other Accessories, arthroscopic devices
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- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
- FIRSTPASS 72290128Smith & Nephew, Inc. · ACCESSORIES,ARTHROSCOPIC232 reports
- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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