n.a. 11161KARecalls & reported problems
Karl Storz GmbH & Co. KG · Biopsy Forceps, flexible, 1 mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551050460), received between Oct 21, 2020 and Jul 28, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Mechanical Problem2
Patient problems
- Insufficient Information2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THERE WAS EVENT WITH A 11161KA BIOPSY FORCEPS FLEXIBLE. THE HANDLE ON THE BIOPSY GRASPER FAILED AND DID NOT OPEN OR CLOSE. THE PROCEDURE WAS CEASED AND RESCHEDULED FOR ANOTHER DAY. PER THE OR NURSE NO INJURY TO THE PATIENT AS IT WAS NEVER INSERTED INTO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 17415116 ↗MalfunctionOct 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4): DURING THE SURGERY THE TIP OF CYSTOSCOPE FRACTURED AND COULD NOT BE REMOVED. NO INJURY; HOWEVER THE TIP COULD NOT BE RETRIEVED DURING THE PROCEDURE. THE PATIENT UNDERWENT SUBSEQUENT MINOR SURGERY AND THE CYSTOSCOPE TIP WAS RETRIEVED FROM THE BLADDER WITHOUT ANY CONCERN.
Patient problems: Insufficient Information
MAUDE report 10713006 ↗MalfunctionOct 21, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN GERMANY: THE BIOPSY FORCEPS GOT STUCK INSIDE THE PATIENT AS THE JAWS COULD NOT BE CLOSED SO THEY COULD NOT BE WITHDRAWN FROM THE ENDOSCOPE.
Patient problems: Foreign Body In Patient
MAUDE report 10713005 ↗
Other ENDOSCOPE, NEUROLOGICAL devices
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- VS3-IR 174-0012Visionsense Ltd. · Endoscope, Neurological1 recall1 report
- Aurora® Surgiscope® ASX9/130Integra Lifesciences Corporation · Endoscope, neurological1 recall0 reports
- IMAGE1 S CONNECT TC201USKarl Storz GmbH & Co. KG · Endoscope, neurological34 reports
- Artemis AP28-APenumbra, Inc. · Endoscope, Neurological4 deaths31 reports
- NA 1688410105Stryker Corporation · Endoscope, neurological24 reports
- Apollo System AP9Penumbra, Inc. · ENDOSCOPE, NEUROLOGICAL10 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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