SCOPE BUDDY PLUS TUBING SB-110-HU1008Recalls & reported problems
Medivators Inc. · Scope Buddy Plus Tubing, Pentax · 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 00677964082962), received between Sep 16, 2022 and Sep 16, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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.
Most reported problems
Device problems
- Detachment of Device or Device Component6
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.
MalfunctionSep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED TO HEALTH CANADA VIA INCIDENT REPORT ONE OF THE SCOPE BUDDY PLUS TUBING CONNECTIONS WAS DETACHING FROM THE ENDOSCOPE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15440860 ↗MalfunctionSep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED TO HEALTH CANADA VIA INCIDENT REPORT ONE OF THE SCOPE BUDDY PLUS TUBING CONNECTIONS WAS DETACHING FROM THE ENDOSCOPE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15440685 ↗MalfunctionSep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED TO HEALTH CANADA VIA INCIDENT REPORT ONE OF THE SCOPE BUDDY PLUS TUBING CONNECTIONS WAS DETACHING FROM THE ENDOSCOPE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15440586 ↗MalfunctionSep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED TO HEALTH CANADA VIA INCIDENT REPORT ONE OF THE SCOPE BUDDY PLUS TUBING CONNECTIONS WAS DETACHING FROM THE ENDOSCOPE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15440106 ↗MalfunctionSep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED TO HEALTH CANADA VIA INCIDENT REPORT ONE OF THE SCOPE BUDDY PLUS TUBING CONNECTIONS WAS DETACHING FROM THE ENDOSCOPE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15439849 ↗MalfunctionSep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED TO HEALTH CANADA VIA INCIDENT REPORT ONE OF THE SCOPE BUDDY PLUS TUBING CONNECTIONS WAS DETACHING FROM THE ENDOSCOPE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15438784 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page