n.a. 26173KARRecalls & reported problems
Karl Storz GmbH & Co. KG · Macro Needle Holder, 5 mm, 33 cm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551098141), received between Jan 27, 2020 and Jul 29, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Fragmentation1
- Material Separation1
- Output below Specifications1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Break
The following was reported: "During the procedure, the tip of the product in question broke." Furthermore, it was reported that: The patient underwent a CT scan, but no damage was found.
Patient problems: Insufficient Information
MAUDE report 50064048 ↗InjuryJul 29, 2026Break; Output below Specifications
The following was reported: "During the procedure, the tip of the product in question broke." Furthermore, it was reported that: The patient underwent a CT scan, but no damage was found.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50064046 ↗MalfunctionJun 10, 2026Material Fragmentation
THE FOLLOWING WAS REPORTED: SCREW BROKE OFF DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459989 ↗MalfunctionJan 27, 2020Material Separation; Material Separation
PER A VIGILANCE REPORT RECEIVED FROM THE FACTORY IN (B)(4), ALLEGEDLY, THERE WAS AN EVENT THAT OCCURRED AT A HEALTHCARE FACILITY IN (B)(6). DURING SURGERY, THE DISTAL PART OF THE NEEDLE HOLDER FELL APART AND REMAINED IN THE PATIENT'S BODY. THE MEDICAL TEAM WAS UNABLE TO VISUALLY LOCATE THE PART. DURING THE SURGERY, AN X-RAY EXAMINATION WAS PREFORMED TO FIND THE BROKEN PART. THE MEDICAL TEAM DECIDED TO FINISH THE OPERATION. IT IS STILL UNCLEAR IF THEY FOUND THE MISSING PART DURING THE XRAY.
Patient problems: Foreign Body In Patient
MAUDE report 9634509 ↗
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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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