NA 26702050Recalls & reported problems
Karl Storz GmbH & Co. KG · DrillCut-X II Shaver Handpiece GYN · Class 2
Quick summary
This Karl Storz DrillCut-X II Shaver Handpiece GYN is a handpiece used to cut tissue during gynecologic hysteroscopy. The 67 adverse event reports mostly describe the handpiece failing to deliver cutting power, shutting down mid-procedure, jamming, or breaking, along with damaged internal parts; 13 reports involved an injury and no deaths were reported. No recalls name this device. Reports rose from 18 in the earlier 12 months to 49 in the most recent 12.
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
- 63
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 04048551274712), received between May 20, 2025 and Sep 29, 2026 — classified as 13 injuries, 50 malfunctions.
The most frequently reported specific device problem is “Output Problem” (24 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
- Output Problem24
- Defective Component17
- Unexpected Shutdown17
- Mechanical Jam10
- Energy Output Problem6
- Fracture6
- Insufficient Device Problem Information4
- Complete Loss of Power3
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- Insufficient Information10
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941072 ↗MalfunctionSep 29, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940381 ↗MalfunctionSep 29, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938897 ↗MalfunctionSep 21, 2026Overcorrection
Patient problems: Insufficient Information
MAUDE report 50847593 ↗MalfunctionAug 28, 2026Output Problem
Patient problems: Insufficient Information
MAUDE report 50508272 ↗MalfunctionAug 28, 2026Output Problem
Patient problems: Insufficient Information
MAUDE report 50507804 ↗MalfunctionAug 18, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50305983 ↗MalfunctionAug 18, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50305982 ↗MalfunctionAug 18, 2026Output Problem
The following was reported: Blocked. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50305981 ↗MalfunctionJun 5, 2026Output Problem
THE FOLLOWING WAS REPORTED: "THE HANDPIECE CANNOT BE RECOGNIZED WHEN CONNECTED AND E19 WAS PROMPTED IN THE UNIDRIVE CONNECTED."
Patient problems: Insufficient Information
MAUDE report 25411331 ↗MalfunctionJun 2, 2026Output Problem
THE FOLLOWING WAS REPORTED: "BLOCKED."
Patient problems: Insufficient Information
MAUDE report 25365420 ↗MalfunctionJun 1, 2026Mechanical Jam
IT WAS REPORTED THAT ERROR CODE 19. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25356105 ↗MalfunctionJun 1, 2026Mechanical Jam
IT WAS REPORTED "ERROR CODE E19".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350305 ↗MalfunctionMay 29, 2026Mechanical Jam
IT WAS REPORTED THAT "ERROR CODE 19". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25337814 ↗MalfunctionMay 13, 2026Mechanical Jam
IT WAS REPORTED THAT "ERROR CODE "E19"".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25160437 ↗MalfunctionMay 12, 2026Mechanical Jam
IT WAS REPORTED THAT CABLE: DAMAGED AND DURING INITIAL EVALUATION IT WAS FOUND THAT THE MOTOR IS STUCK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153260 ↗MalfunctionMay 11, 2026Defective Component; Output Problem
THE FOLLOWING WAS REPORTED: ERROR E19 WITH UNIDRIVE S III. THE MOTOR IS DEFECTIVE AND NOT DETECTED BY UNIDRIVE SELECT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25142246 ↗MalfunctionApr 28, 2026Output Problem
IT WAS REPORTED: ERROR MESSAGE: DEFECTIVE MOTOR, PLEASE CONTACT KARL STORZ TECHNICAL SERVICE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25023337 ↗MalfunctionApr 16, 2026Insufficient Device Problem Information
IT WAS REPORTED "ERROR CODE "E19". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901472 ↗MalfunctionApr 16, 2026Insufficient Device Problem Information
IT WAS REPORTED "ERROR CODE "E19". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901337 ↗MalfunctionApr 16, 2026Insufficient Device Problem Information
IT WAS REPORTED "ERROR CODE "E09". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24900580 ↗MalfunctionApr 13, 2026Insufficient Device Problem Information
IT WAS REPORTED ERROR CODE "E19". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867182 ↗MalfunctionApr 11, 2026Output Problem
THE FOLLOWING WAS REPORTED: "BLOCKED AND BIG NOISE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24851938 ↗MalfunctionApr 8, 2026Output Problem
THE FOLLOWING WAS REPORTED: "MOTOR JAM, ERROR E19 WHEN USING UNIDRIVE S III." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821214 ↗MalfunctionMar 31, 2026Mechanical Jam
IT WAS REPORTED THAT TOWARDS THE END OF THE PROCEDURE DRILL CUT MOTOR SEIZED AND STOPPED WORKING. THERE WAS NO HARM TO THE USER OR PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24749235 ↗
Other HYSTEROSCOPE (AND ACCESSORIES) devices
- Olympus WA2T430AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)783 reports
- Olympus WA2T412AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)453 reports
- Olympus A22001AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)366 reports
- Olympus WA2T470AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)323 reports
- Olympus A22002AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)297 reports
- Olympus A22003AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)198 reports
- n.a. 27040XAKarl Storz GmbH & Co. KG · HYSTEROSCOPE (AND ACCESSORIES)102 reports
- Myosure Reach Tissue Removal Device 10-401FCHologic, Inc. · HYSTEROSCOPE (AND ACCESSORIES)4 deaths99 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.