n.a. 26173KALRecalls & 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
Quick summary
This Karl Storz Macro Needle Holder is a laparoscopic surgical instrument used to grasp needles during minimally invasive surgery. Reports mostly describe the instrument breaking during use, with pieces of material separating or fragmenting and sometimes left inside the patient. There are 29 reports, including 9 injuries and no deaths. No recalls name this device. Reports have risen sharply, from 4 in the prior 12 months to 15 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04048551098127), received between Oct 3, 2019 and Sep 21, 2026 — classified as 9 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Break” (15 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
- Break15
- Material Fragmentation9
- Detachment of Device or Device Component3
- Material Separation3
- Crack2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Foreign Body In Patient6
- Unintended Radiation Exposure2
- Patient Problem/Medical Problem1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849121 ↗MalfunctionAug 26, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458752 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50040128 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50040125 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50040124 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50017304 ↗MalfunctionMay 22, 2026Break
IT WAS REPORTED THAT "DURING A ROUTINE CHECK A LAPAROSCOPIC VISE HAS SUFFERED A BREAK IN ITS CONSTRUCTION".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25262631 ↗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 24941991 ↗MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT WHEN THE DOCTOR TRIED TO GRAB THE NEEDLE, SYSTEM THAT OPERATE THE JAWS BROKE. THERE WAS A DELAY OF 10 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24900082 ↗MalfunctionApr 7, 2026Break
THE FOLLOWING WAS REPORTED: "DURING A ROUTINE CHECK - BROKEN RIVET". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801859 ↗MalfunctionFeb 19, 2026Break
WAS REPORTED THAT "THE NEEDLE HOLDER BECAME IMMOBILE AND WAS EXAMINED OUTSIDE THE SURGICAL FIELD. DAMAGE TO THE MOVABLE TIP WAS CONFIRMED, AND THE SURGICAL FIELD WAS IMMEDIATELY CHECKED FOR ANY DISLODGEMENT. NO DISLODGEMENT WAS DETECTED ON THE POSTOPERATIVE X-RAY".
Patient problems: Unintended Radiation Exposure
MAUDE report 24393848 ↗InjuryFeb 19, 2026Break
WAS REPORTED THAT "THE NEEDLE HOLDER BECAME IMMOBILE AND WAS EXAMINED OUTSIDE THE SURGICAL FIELD. DAMAGE TO THE MOVABLE TIP WAS CONFIRMED, AND THE SURGICAL FIELD WAS IMMEDIATELY CHECKED FOR ANY DISLODGEMENT. NO DISLODGEMENT WAS DETECTED ON THE POSTOPERATIVE X-RAY".
Patient problems: Unintended Radiation Exposure
MAUDE report 24393847 ↗InjuryFeb 17, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE LOST ITS GRIP AND A FRAGMENT APPEARED TO BE MISSING. AN ADDITIONAL X-RAY WAS TAKEN AND THE FRAGMENT WAS FOUND ON THE X-RAY. BUT IT WAS NOT POSSIBLE TO RETRIEVE THE BROKEN PART. DUE TO A FRAGMENT REMAINED IN SITU THIS CASE IS DEEMED REPORTABLE.
Patient problems: Foreign Body In Patient
MAUDE report 24366368 ↗InjuryFeb 17, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE LOST ITS GRIP AND A FRAGMENT APPEARED TO BE MISSING. AN ADDITIONAL X-RAY WAS TAKEN AND THE FRAGMENT WAS FOUND ON THE X-RAY. BUT IT WAS NOT POSSIBLE TO RETRIEVE THE BROKEN PART. DUE TO A FRAGMENT REMAINED IN SITU THIS CASE IS DEEMED REPORTABLE.
Patient problems: Foreign Body In Patient
MAUDE report 24366366 ↗MalfunctionNov 19, 2025Material Fragmentation; Material Fragmentation
ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE "BROKE". ACCORDING TO THE PRELIMINARY INVESTIGATION IT BROKE ON THE JOINT OF THE JAWS. 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 23599996 ↗MalfunctionNov 19, 2025Material Fragmentation; Material Fragmentation
ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE "BROKE". ACCORDING TO THE PRELIMINARY INVESTIGATION IT BROKE ON THE JOINT OF THE JAWS. 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 23599671 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT "THE JOINT AT THE HEAD END OF THE NEEDLE HOLDER BROKE. IT OCCURRED WHEN COVIDIEN 3-0VLOCK NEEDLE WAS BEING SUTURED. THE FRAGMENT DROPPED DURING THE PROCEDURE, AND IMMEDIATELY FOUND AND REMOVED BY THE DOCTOR." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974334 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT "THE JOINT AT THE HEAD END OF THE NEEDLE HOLDER BROKE. IT OCCURRED WHEN COVIDIEN 3-0VLOCK NEEDLE WAS BEING SUTURED. THE FRAGMENT DROPPED DURING THE PROCEDURE, AND IMMEDIATELY FOUND AND REMOVED BY THE DOCTOR." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974333 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT "BEFORE PROCEDURE, IT WAS FOUND THE SCREW HAS COME OFF AND CANNOT BE RE-TIGHTENED. THE INTERNAL THREADS HAVE BECOME WORN." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974332 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT "THE JOINT AT THE HEAD END OF THE NEEDLE HOLDER BROKE. IT OCCURRED WHEN COVIDIEN 3-0VLOCK NEEDLE WAS BEING SUTURED. THE FRAGMENT DROPPED DURING THE PROCEDURE, AND IMMEDIATELY FOUND AND REMOVED BY THE DOCTOR." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974331 ↗InjuryMay 14, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DOCTOR STITCHED THE INCISION AFTER THE HYSTEROMYECTOMY OF THE PATIENT. AFTER STITCHING ONLY 1-2 STITCHES, THE DOCTOR HEARD A "SNAP" SOUND OF THE NEEDLE HOLDER. AFTER REMOVING THE NEEDLE HOLDER, THE NURSE FOUND THAT THERE WERE SMALL PIECES OF THE NEEDLE HOLDER MISSING. THE INSTRUMENT NURSE SHOOK THE NEEDLE HOLDER AND FOUND TWO SMALL FRAGMENTS. THE DOCTOR USED A MAGNET TO SUCK THE SURFACE OF THE ABDOMINAL ORGANS AND DID NOT SUCK OUT MISSING PARTS. THE HOSPITAL CONTACT THE MANUFACTURER TO REPORT THAT THE MAIN MISSING TWO PIECES ARE FOUND, BUT THERE MAY HAVE DEBRIS REMAIN. INTRAOPERATIVE C-ARM FLUOROSCOPY WAS PERFORMED WITH TWO DIFFERENT MODES AND NO RESIDUAL WAS FOUND. THE DIRECTOR OF THE REPORT AND THE SUPERIOR DEPUTY CONSULTANT CONSIDERED THAT THE POSSIBILITY OF PIECES REMAINING IN THE BODY WAS SMALL, AND NO HARM WAS CAUSED TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19315836 ↗InjuryMay 14, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DOCTOR STITCHED THE INCISION AFTER THE HYSTEROMYECTOMY OF THE PATIENT. AFTER STITCHING ONLY 1-2 STITCHES, THE DOCTOR HEARD A "SNAP" SOUND OF THE NEEDLE HOLDER. AFTER REMOVING THE NEEDLE HOLDER, THE NURSE FOUND THAT THERE WERE SMALL PIECES OF THE NEEDLE HOLDER MISSING. THE INSTRUMENT NURSE SHOOK THE NEEDLE HOLDER AND FOUND TWO SMALL FRAGMENTS. THE DOCTOR USED A MAGNET TO SUCK THE SURFACE OF THE ABDOMINAL ORGANS AND DID NOT SUCK OUT MISSING PARTS. THE HOSPITAL CONTACT THE MANUFACTURER TO REPORT THAT THE MAIN MISSING TWO PIECES ARE FOUND, BUT THERE MAY HAVE DEBRIS REMAIN. INTRAOPERATIVE C-ARM FLUOROSCOPY WAS PERFORMED WITH TWO DIFFERENT MODES AND NO RESIDUAL WAS FOUND. THE DIRECTOR OF THE REPORT AND THE SUPERIOR DEPUTY CONSULTANT CONSIDERED THAT THE POSSIBILITY OF PIECES REMAINING IN THE BODY WAS SMALL, AND NO HARM WAS CAUSED TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19315835 ↗MalfunctionNov 21, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A SURGERY THE NEEDLE HOLDER IS STRETCHED AND BROKEN. FRAGMENTS FELL INTO PATIENTS' BODY BUT WERE ALL RETRIEVED ACCORDINGLY. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18184711 ↗InjurySep 28, 2023Crack; Material Fragmentation; Crack; Material Fragmentation
IT WAS REPORTED THAT AFTER COMPLETING THE SURGERY ON THE PATIENT, THE SURGEON NOTICED THAT THE TIP OF THE NEEDLE HOLDER WAS BROKEN. AFTER THE SURGERY, AN X-RAY EXAMINATION CONFIRMED THAT THE DAMAGED FRAGMENT REMAINED. IT WILL BE COLLECTED. THE BROKEN TIP REMAINED IN PATIENT AND A FURTHER SURGERY TO RECOVER THE PIECE IS LIKELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17837265 ↗InjurySep 28, 2023Crack; Material Fragmentation; Crack; Material Fragmentation
IT WAS REPORTED THAT AFTER COMPLETING THE SURGERY ON THE PATIENT, THE SURGEON NOTICED THAT THE TIP OF THE NEEDLE HOLDER WAS BROKEN. AFTER THE SURGERY, AN X-RAY EXAMINATION CONFIRMED THAT THE DAMAGED FRAGMENT REMAINED. IT WILL BE COLLECTED. THE BROKEN TIP REMAINED IN PATIENT AND A FURTHER SURGERY TO RECOVER THE PIECE IS LIKELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17836795 ↗
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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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