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CLICKLINE 28164LBARecalls & reported problems

Karl Storz GmbH & Co. KG · CLICKLINE Insert Scissors, pointed · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551007815), received between Jun 12, 2024 and Jun 12, 2024 — classified as 1 injury, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 2 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component2
  • Solder Joint Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 12, 2024Solder Joint Fracture; Detachment of Device or Device Component; Solder Joint Fracture; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A RIGHT FRONTAL NEURO ENDOSCOPIC ARACHNOID CYST FENESTRATION ON (B)(6) 2024, THE SCISSORS BROKE. THEY WERE ABLE TO COMPLETE THE PROCEDURE BY USING A BIOPSY FORCEP SINCE THEY USED THE SCISSOR FOR MAJORITY OF THE PROCEDURE UNTIL IT STOPPED WORKING PROPERLY. THERE WAS NO PATIENT INJURY REPORTED. PATIENT HAD CT SCAN TO ENSURE SCISSORS DID NOT BREAK INSIDE OF THE PATIENT, AND NOTHING WAS FOUND PER THE CT RESULT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19524993 ↗
  • InjuryJun 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A RIGHT FRONTAL NEURO ENDOSCOPIC ARACHNOID CYST FENESTRATION ON (B)(6) 2024, THE SCISSORS BROKE. THEY WERE ABLE TO COMPLETE THE PROCEDURE BY USING A BIOPSY FORCEP SINCE THEY USED THE SCISSOR FOR MAJORITY OF THE PROCEDURE UNTIL IT STOPPED WORKING PROPERLY. THERE WAS NO PATIENT INJURY REPORTED. PATIENT HAD CT SCAN TO ENSURE SCISSORS DID NOT BREAK INSIDE OF THE PATIENT, AND NOTHING WAS FOUND PER THE CT RESULT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19524992 ↗

Other ENDOSCOPE, NEUROLOGICAL devices

All ENDOSCOPE, NEUROLOGICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.