NA 26173HARecalls & reported problems
Karl Storz GmbH & Co. KG · Needle Holder · Class 1
- 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 04048551387405), received between Aug 30, 2022 and Apr 21, 2026 — classified as 3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Break
IT WAS REPORTED THAT "INSTRUMENT WAS PURCHASED ON (B)(6) 2026 AND BROKE 4 WEEKS LATER". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942508 ↗MalfunctionMar 7, 2026No Display/Image
CUSTOMER COMPLAINS ABOUT BUILD QUALITY, AS PRODUCT IS DEFECTIVE AFTER ONLY 8 WEEKS: FAULT: A PART HAS BROKEN OFF AT THE MOUTH. NO PATIENT INVOLVEMENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24540427 ↗MalfunctionAug 30, 2022Break; Break
AS PER A MANUFACTURER INCIDENT REPORT (B)(4) RECEIVED FROM THE FACTORY IN GERMANY: IT WAS REPORTED THAT THE PHYSICIAN USED THE DEVICE FOR SUTURE DURING AN OVARIAN CYST REMOVING SURGERY ON (B)(6) 2022. THE TIP OF THE NEEDLE HOLDER BROKE UNDER NORMAL USE AND FELL INTO THE PATIENT'S ABDOMEN. IN ORDER TO RETRIEVE THE FALLEN PART, THE USER PROLONGED THE ANESTHESIA TIME AND USED C-ARM X-RAY TO LOCATE THE BROKEN JAW. THE OPERATION TIME WAS EXTENDED FOR MORE THAN TWO HOURS. THE DETACHED PART WAS FOUND SUCCESSFULLY. IN ORDER TO MAKE SURE THE PATIENT'S OVERALL HEALTH AND SAFETY, THE HOSPITALIZATION WAS PROLONGED FOR 3 DAYS. THERE WERE NO LONG TERM INJURIES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15323988 ↗
Other HOLDER, NEEDLE, GASTROENTEROLOGIC devices
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- Capio RP M0068321010Boston Scientific Corporation · HOLDER, NEEDLE, GASTROENTEROLOGIC1 recall0 reports
- Integra® Jarit® 121135Integra Lifesciences Production Corporation · HOLDER, NEEDLE, GASTROENTEROLOGIC4 reports
- Integra® Jarit® 121210Integra Lifesciences Production Corporation · HOLDER, NEEDLE, GASTROENTEROLOGIC2 reports
- V. Mueller RH2551Steris Corporation · HOLDER, NEEDLE, GASTROENTEROLOGIC1 report
- Integra® Jarit® 120135Integra Lifesciences Production Corporation · HOLDER, NEEDLE, GASTROENTEROLOGIC1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.