n.a. 27290KRecalls & reported problems
Karl Storz GmbH & Co. KG · Forceps · Class 2
- 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 04048551082485), received between Jan 17, 2019 and Sep 15, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation2
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781817 ↗InjuryDec 19, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE FORCEPS BROKE OFF. THE BROKEN PART INCLUDED WITH THE FORCEPS WAS RETRIEVED AFTER THE PROCEDURE. WE REQUEST CONFIRMATION THAT NO OTHER BROKEN PARTS (FRAGMENTS) ARE PRESENT. THEY WERE NOT VISIBLE ON X-RAY OR CT IMAGES. SINCE IT WAS INDICATED THAT MEDICAL/ SURGICAL/ DIAGNOSTICAL INTERVENTION WAS REQUIRED AND IT COULD NOT YET BE CONFIRMED IF OTHER FRAGMENTS ARE PRESENT, THIS CASE IS DEEMED REPORTABLE.
Patient problems: Insufficient Information
MAUDE report 23854601 ↗InjuryDec 19, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE FORCEPS BROKE OFF. THE BROKEN PART INCLUDED WITH THE FORCEPS WAS RETRIEVED AFTER THE PROCEDURE. WE REQUEST CONFIRMATION THAT NO OTHER BROKEN PARTS (FRAGMENTS) ARE PRESENT. THEY WERE NOT VISIBLE ON X-RAY OR CT IMAGES. SINCE IT WAS INDICATED THAT MEDICAL/ SURGICAL/ DIAGNOSTICAL INTERVENTION WAS REQUIRED AND IT COULD NOT YET BE CONFIRMED IF OTHER FRAGMENTS ARE PRESENT, THIS CASE IS DEEMED REPORTABLE.
Patient problems: Insufficient Information
MAUDE report 23851341 ↗MalfunctionJan 17, 2019Material Separation; Material Separation
ALLEGEDLY, DURING A PCNL PROCEDURE, ONE OF THE JAWS OF THE STONE GRASPING FORCEPS BROKE OFF INSIDE THE PATIENT. THE BROKEN JAW WAS RETRIEVED. THERE WAS NO HARM TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8259130 ↗
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- MIP Minimal Invasive PCNL 27840KAKarl Storz GmbH & Co. KG · Kit, nephroscope1 recall3 reports
- HALOGEN LIGHT SOURCE CLH-SCOlympus Medical Systems Corp. · Kit, nephroscope37 reports
- Olympus WA33036AOLYMPUS Winter & Ibe GmbH · Kit, Nephroscope27 reports
- Olympus A37025AOLYMPUS Winter & Ibe GmbH · Kit, Nephroscope4 deaths20 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5AOlympus Medical Systems Corp. · Kit, nephroscope9 reports
- n.a. 27290MKarl Storz GmbH & Co. KG · Kit, nephroscope4 reports
- PANOVIEW PLUS 8965401Richard Wolf GmbH · Kit, nephroscope2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.