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CLICKLINE 33410ONRecalls & reported problems

Karl Storz GmbH & Co. KG · CLICKLINE Forceps Insert · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551143285), received between Feb 18, 2025 and Feb 18, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 4 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 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available4
  • Insufficient Device Problem Information4
  • Break1
  • Sharp Edges1
  • Use of Device Problem1

Patient problems

  • Perforation4
  • Insufficient Information2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 18, 2025Break; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Sharp Edges; Break; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Sharp Edges

    IT WAS REPORTED THAT THE ATRAUMATIC GRASPER CREATED A TEAR/HOLE ON THE STOMACH, AND IT WAS NOT BEING PULLED ON. THE SURGEON SAID THAT SHE WOULD HAVE NEEDED TO SUTURE THE HOLES, HAD THAT PART OF THE STOMACH REMAINED INSIDE THE PATIENT. FORTUNATELY, IT WAS THE PART OF THE STOMACH THAT WAS REMOVED FROM THE BODY. THE SURGEON MENTIONED THAT IT HAPPENED IN ANOTHER CASE A WEEK OR TWO AGO. CROSS REFERENCE MDR: 9610617-2025-00241.

    Patient problems: Insufficient Information; Perforation

    MAUDE report 21398760 ↗
  • InjuryFeb 18, 2025Use of Device Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE ATRAUMATIC GRASPER CREATED A TEAR/HOLE ON THE STOMACH, AND IT WAS NOT BEING PULLED ON. THE SURGEON SAID THAT SHE WOULD HAVE NEEDED TO SUTURE THE HOLES, HAD THAT PART OF THE STOMACH REMAINED INSIDE THE PATIENT. FORTUNATELY, IT WAS THE PART OF THE STOMACH THAT WAS REMOVED FROM THE BODY. THE SURGEON MENTIONED THAT IT HAPPENED IN ANOTHER CASE A WEEK OR TWO AGO. CROSS REFERENCE MDR 9610617-2025-00242.

    Patient problems: Insufficient Information; Perforation

    MAUDE report 21396032 ↗
  • InjuryFeb 18, 2025Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE ATRAUMATIC GRASPER CREATED A TEAR/HOLE ON THE STOMACH, AND IT WAS NOT BEING PULLED ON. THE SURGEON SAID THAT SHE WOULD HAVE NEEDED TO SUTURE THE HOLES, HAD THAT PART OF THE STOMACH REMAINED INSIDE THE PATIENT. FORTUNATELY, IT WAS THE PART OF THE STOMACH THAT WAS REMOVED FROM THE BODY. THE SURGEON MENTIONED THAT IT HAPPENED IN ANOTHER CASE A WEEK OR TWO AGO. CROSS REFERENCE MDR 9610617-2025-00241.

    Patient problems: Perforation

    MAUDE report 21393856 ↗
  • InjuryFeb 18, 2025Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE ATRAUMATIC GRASPER CREATED A TEAR/HOLE ON THE STOMACH, AND IT WAS NOT BEING PULLED ON. THE SURGEON SAID THAT SHE WOULD HAVE NEEDED TO SUTURE THE HOLES, HAD THAT PART OF THE STOMACH REMAINED INSIDE THE PATIENT. FORTUNATELY, IT WAS THE PART OF THE STOMACH THAT WAS REMOVED FROM THE BODY. THE SURGEON MENTIONED THAT IT HAPPENED IN ANOTHER CASE A WEEK OR TWO AGO. CROSS REFERENCE MDR 9610617-2025-00242.

    Patient problems: Perforation

    MAUDE report 21393593 ↗

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