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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 31310C
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 01/13/2025
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
Event or Problem Description
It was reported that a part jaw part of the intestinal grasping forceps has broken off during procedure and remained in the patient.Further surgery was necessary to remove the foreign body.
 
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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 Key21214385
Report Number2020550-2025-00039
Device Sequence Number16975692
Product Code GCJ
UDI-Device Identifier04048551333723
UDI-Public04048551333723
Combination Product (Y/N)N
Initial Reporter CountryGM
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) 01/22/2025
Report Date (Section F) 01/22/2025
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 Number31310C
Device Catalogue Number31310C
Device Lot NumberWM07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/15/2025
Event Location Hospital
Date Report to Manufacturer01/22/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/22/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
38910MD ROBI FORCEPS INSERT WITH OUTER SHEATH
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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