n.a. 11161AB-SRecalls & reported problems
Karl Storz GmbH & Co. KG · MONOPLR ELECTRODE, 1MM, STERILE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551392546), received between Mar 10, 2022 and Mar 19, 2022 — classified as 1 death, 2 malfunctions.
The most frequently reported specific device problem is “Intermittent Loss of Power” (3 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
Device problems
- Intermittent Loss of Power3
Patient problems
- Insufficient Information2
- Brain Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2022Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THE CUSTOMER HAD THREE INCIDENTS INVOLVING PART # 11161AB-S (BUGBEE ELECTRODE). THE ITEM WORKED EITHER INTERMITTENTLY OR NOT AT ALL, DURING OUR INVESTIGATION OF THE EVENT, THE FACILITY HAD NO FURTHER INFORMATION TO PROVIDE.
Patient problems: Insufficient Information
MAUDE report 13826708 ↗MalfunctionMar 19, 2022Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THE CUSTOMER HAD THREE INCIDENTS INVOLVING PART # 11161AB-S (BUGBEE ELECTRODE). THE ITEM WORKED EITHER INTERMITTENTLY OR NOT AT ALL. DURING OUR INVESTIGATION OF THE EVENT, THE FACILITY HAD NO FURTHER INFORMATION TO PROVIDE.
Patient problems: Insufficient Information
MAUDE report 13826568 ↗DeathMar 10, 2022Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THE CUSTOMER HAD THREE INCIDENTS INVOLVING PART # 11161AB-S (BUGBEE ELECTRODE) - ONE OF THEM LEADING TO A PASSING OF A PATIENT. THE ITEM WORKED EITHER INTERMITTENTLY OR NOT AT ALL. DURING OUR INVESTIGATION OF THE EVENT, THE FACILITY STATED PROFOUND BRAIN DAMAGE, AND THE FAMILY DECIDE TO WITHDRAW HELP. REASON: NEUROLOGICAL DEVASTATION.
Patient problems: Brain Injury
MAUDE report 13725281 ↗
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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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