NA 5140-525-608Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Monopolar Probe 85mm, straight, flex · Class 2
Data updated Oct 18, 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 07613327282238), received between Jul 18, 2019 and Jul 18, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver Energy” (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 18, 2026.
Most reported problems
Device problems
- Failure to Deliver Energy2
- No Display/Image1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2019No Display/Image; Failure to Deliver Energy; No Display/Image; Failure to Deliver Energy
THE USER FACILITY REPORTED THE DEVICE DIDN'T PROVIDE STIMULATION DURING USE IN A SURGICAL PROCEDURE. THIS CONDITION, IN WHICH THE DEVICE DOES NOT DELIVER ENERGY, MAY BE INTERPRETED BY THE USER AS A FALSE NEGATIVE RESULT, OR MAY RESULT IN THE LOSS OF OF ABILITY TO NERVE MONITOR, POSING INCREASED RISK OF NERVE INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT THE USE OF NERVE MONITORING. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8804333 ↗MalfunctionJul 18, 2019Failure to Deliver Energy; Failure to Deliver Energy
THE USER FACILITY REPORTED THE DEVICE DIDN'T PROVIDE STIMULATION DURING USE IN A SURGICAL PROCEDURE. THIS CONDITION, IN WHICH THE DEVICE DOES NOT DELIVER ENERGY, MAY BE INTERPRETED BY THE USER AS A FALSE NEGATIVE RESULT, OR MAY RESULT IN THE LOSS OF OF ABILITY TO NERVE MONITOR, POSING INCREASED RISK OF TRANSECTION OF A NERVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8803696 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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