ROBI 38610MWRecalls & reported problems
Karl Storz GmbH & Co. KG · RoBi Scissors Insert · Class 2
All models of ROBI (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048551328750), received between Aug 11, 2017 and Aug 6, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component4
- Fracture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Fracture
It was reported that damaged after approximately 3 months of use. Plastic hinge part chipped. Two cracks confirmed at insert hinge area. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164332 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
IT WAS ONLY REPORTED THAT THE MOUTHPIECE CERAMIC IS BROKEN OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24719861 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT "CERAMIC LAYER COMING OFF". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693893 ↗InjuryJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A LOSS OF A CERAMIC INLAY ON A 38610MW POST OP WAS DETECTED. THE WHEREABOUTS OF THE CERAMIC INLAY IN THE PATIENT WAS CONFIRMED BY X-RAY CONTROL. ACCORDING TO A TELEPHONE CALL, THERE ARE CURRENTLY NO PLANS TO SURGICALLY REMOVE THE CERAMIC INLAY.
Patient problems: Foreign Body In Patient
MAUDE report 19645015 ↗InjuryJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A LOSS OF A CERAMIC INLAY ON A 38610MW POST OP WAS DETECTED. THE WHEREABOUTS OF THE CERAMIC INLAY IN THE PATIENT WAS CONFIRMED BY X-RAY CONTROL. ACCORDING TO A TELEPHONE CALL, THERE ARE CURRENTLY NO PLANS TO SURGICALLY REMOVE THE CERAMIC INLAY.
Patient problems: Foreign Body In Patient
MAUDE report 19645013 ↗MalfunctionAug 11, 2017Material Separation; Material Separation
ALLEGEDLY, THE DOCTOR WAS PERFORMING A PROCEDURE WHEN HE NOTED THAT A PIECE CAME OFF ONE OF THE JAWS INTO THE PATIENT. HE IMMEDIATELY RETRIEVED PIECE, REPLACED INSTRUMENT AND COMPLETED PROCEDURE. THE HOSPITAL REPORTED THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6789971 ↗
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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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