SCOPE BUDDY PLUS TUBING SB-110-HU1007Recalls & reported problems
Medivators Inc. · Scope Buddy Plus Tubing, Olympus · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00677964082924), received between Mar 24, 2022 and Jun 5, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash4
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE SCOPE BUDDY PLUS TUBING DISCONNECTED FROM THEIR SCOPE BUDDY PLUS ENDOSCOPE FLUSHING AID SUBSEQUENTLY CAUSING WATER TO CONTACT THE WALL OUTLET IN WHICH THE DEVICE WAS PLUGGED INTO. USER FACILITY PERSONNEL OBSERVED A "SPARK" FROM THE WALL OUTLET AND UNPLUGGED THE DEVICE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22152309 ↗MalfunctionOct 4, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR SCOPE BUDDY PLUS TUBING DETACHED FROM THE ENDOSCOPE SPRAYING WATER ONTO USER FACILITY PERSONNEL. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20376832 ↗MalfunctionMar 7, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR SCOPE BUDDY PLUS TUBING DETACHES FROM THE ENDOSCOPE SPRAYING WATER ONTO USER FACILITY PERSONNEL. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18855344 ↗MalfunctionNov 21, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AS AN EMPLOYEE WAS FLUSHING AN ENDOSCOPE WITH THEIR SCOPE BUDDY PLUS, THE AIR CONNECTION HOOKUP FROM THE SCOPE BUDDY PLUS OLYMPUS TUBING "POPPED OFF" SUBSEQUENTLY CAUSING SINK WATER TO SPRAY ONTO EMPLOYEES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18183915 ↗MalfunctionNov 17, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AS AN EMPLOYEE WAS FLUSHING AN ENDOSCOPE WITH THEIR SCOPE BUDDY PLUS, THE AIR CONNECTION HOOKUP FROM THE SCOPE BUDDY PLUS OLYMPUS TUBING "POPPED OFF" SUBSEQUENTLY CAUSING SINK WATER TO SPRAY ONTO EMPLOYEES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18161863 ↗MalfunctionMar 24, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE USER FACILITY REPORTED THAT THEIR SCOPE BUDDY PLUS TUBING WAS SLIDING OFF DURING FLUSHING OF ENDOSCOPES AND THE SINK WATER IS BEING SPRAYED ONTO EMPLOYEES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13873806 ↗
Other Accessories, Cleaning, For Endoscope devices
- ENDOSCOPE REPROCESSOR OER-ProOlympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE3 recalls1,163 reports
- ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · Accessories, cleaning, for endoscope4 recalls323 reports
- SINGLE USE DISTAL COVER MAJ-2315Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls294 reports
- CONNECTING TUBE MAJ-2110Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall213 reports
- CONNECTING TUBE MAJ-2111Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall164 reports
- CONNECTING TUBE MAJ-2113Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall159 reports
- CONNECTING TUBE MAJ-2112Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall143 reports
- ENDOSCOPE REPROCESSOR OER-MINIOlympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls11 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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