CLICKLINE 33400Recalls & reported problems
Karl Storz GmbH & Co. KG · Metal Outer Sheath, insulated, 43 cm · Class 2
All models of CLICKLINE (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551142707), received between Apr 20, 2018 and Mar 30, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Break1
- Chemical Problem1
- Material Separation1
- Mechanical Problem1
Patient problems
- Foreign Body In Patient3
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING LAPAROSCOPIC SURGERY ON THE SIGMOID COLON, THE SURGEON NOTICED A MALFUNCTION IN THE JOHANNE MULTI-PURPOSE GRASPING FORCEPS, RESULTING IN THE DETACHMENT OF A SMALL METAL FRAGMENT INTO THE ABDOMEN. THE FRAGMENT WAS IMMEDIATELY IDENTIFIED AND RETRIEVED WITHOUT CAUSING ANY HARM TO THE PATIENT. AN ABDOMINAL X-RAY WAS PERFORMED TO RULE OUT THE PRESENCE OF OTHER FRAGMENTS, WITH NEGATIVE RESULTS. IT SHOULD BE NOTED THAT THE INSTRUMENT WAS FUNCTIONING CORRECTLY AT THE START OF THE PROCEDURE. THE PATIENT WAS SUBMITTED TO ADDITIONAL X-RAY CHECK-UP NOT FORESEEN, WITH EXTENSION OF SURGICAL PROCEDURE. SINCE THE ADDITIONAL X RAY WAS REQUIRED, THIS CASE IS REPORTABLE.
Patient problems: Foreign Body In Patient
MAUDE report 24708750 ↗InjuryMar 30, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING LAPAROSCOPIC SURGERY ON THE SIGMOID COLON, THE SURGEON NOTICED A MALFUNCTION IN THE JOHANNE MULTI-PURPOSE GRASPING FORCEPS, RESULTING IN THE DETACHMENT OF A SMALL METAL FRAGMENT INTO THE ABDOMEN. THE FRAGMENT WAS IMMEDIATELY IDENTIFIED AND RETRIEVED WITHOUT CAUSING ANY HARM TO THE PATIENT. AN ABDOMINAL X-RAY WAS PERFORMED TO RULE OUT THE PRESENCE OF OTHER FRAGMENTS, WITH NEGATIVE RESULTS. IT SHOULD BE NOTED THAT THE INSTRUMENT WAS FUNCTIONING CORRECTLY AT THE START OF THE PROCEDURE. THE PATIENT WAS SUBMITTED TO ADDITIONAL X-RAY CHECK-UP NOT FORESEEN, WITH EXTENSION OF SURGICAL PROCEDURE. SINCE THE ADDITIONAL X RAY WAS REQUIRED, THIS CASE IS REPORTABLE.
Patient problems: Foreign Body In Patient
MAUDE report 24708749 ↗MalfunctionDec 23, 2025Break; Chemical Problem; Break; Chemical Problem
IT WAS REPORTED THAT THE DEVICE IS BROKEN/JAMMED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-02419.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879089 ↗MalfunctionApr 11, 2019Mechanical Problem; Mechanical Problem
ALLEGEDLY, THE INSULATION ON THE SHAFT OF THE INSTRUMENT FELL OFF IN THE PATIENT DURING A PROCEDURE. THEY WERE ABLE TO RETRIEVE ALL PIECES AND IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT.
Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem
MAUDE report 8505531 ↗MalfunctionApr 20, 2018Material Separation; Material Separation
ALLEGEDLY, DURING A ROBOTIC CHOLECYSTECTOMY PROCEDURE, PIECES OF INSULATION CAME OFF INSIDE THE PATIENT. THE DOCTOR USED ANOTHER INSTRUMENT AND COMPLETED THE PROCEDURE WITH NO INJURY TO THE PATIENT. HOSPITAL REPORTED THAT THE INSULATION PIECES WERE RECOVERED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7449118 ↗
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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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