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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE FORCEPS INSERT
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KARL STORZ SE & CO. KG CLICKLINE FORCEPS INSERT Back to Search Results
Model Number 33310C
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/25/2025
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
 
Event or Problem Description
According to the information received, during a laparoscopic bowel resection the tip of the 33310c clickline forceps insert broke/came off.The broken tip was successfully retrieved under x-ray guidance with no injury to the patient.
 
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Brand Name
CLICKLINE FORCEPS INSERT
Common Device Name
CLICKLINE FORCEPS INSERT
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key23791639
Report Number2020550-2025-02324
Device Sequence Number17529434
Product Code GCJ
UDI-Device Identifier04048551134092
UDI-Public04048551134092
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/12/2025
Report Date (Section F) 12/12/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number33310C
Device Catalogue Number33310C
Device Lot NumberTU12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/28/2025
Event Location Hospital
Date Report to Manufacturer12/12/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/12/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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