n.a. 26173KCRecalls & reported problems
Karl Storz GmbH & Co. KG · Macro Needle Holder, 5 mm, 33 cm · Class 2
Data updated Oct 13, 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 04048551098165), received between Aug 26, 2024 and Aug 27, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Insufficient Device Problem Information1
- Material Fragmentation1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Break; Break
IT WAS REPORTED THAT "DURING THE SURGERY, THE JAW PART OF THE DEVICE BROKE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 22904193 ↗MalfunctionAug 26, 2024Material Fragmentation; Insufficient Device Problem Information; Material Fragmentation; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGERY IN THE OBSTETRICS AND GYNECOLOGY DEPARTMENT, THE DEVICE, WITH THE NEEDLE SECURED AND INSERTED INTO THE BODY, EXPERIENCED AN AUTOMATIC RELEASE OF THE LOCKING MECHANISM, CAUSING THE NEEDLE TO EJECT. THE DEVICE MALFUNCTIONED AS A RESULT. THE OPERATING ROOM STAFF PERFORMED AN X-RAY TO CHECK FOR ANY REMAINING COMPONENTS INSIDE THE BODY, BUT NO COMPONENTS WERE FOUND. AS ADDITIONAL X-RAY WERE PERFORMED AND NO MISSING COMPONENTS WERE FOUND INSIDE THE BODY, A REPORT IS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20066206 ↗
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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 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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