MAUDE Adverse Event Report: KARL STORZ SE & CO. KG AUTOMATIC VALVE, SIZE 12 MM

Model Number	30104A1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
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
The following was reported: received phone call from (b)(6) sisters (b)(6), told that the trocar was found to be faulty as there is leaking of gas.Closer look at the trocar revealed to have a missing screw.Screw is suspected to came loose and worried that it might drop into patient.An x-ray scan was performed to confirm that no metal residue remained in the patient's body.The scan returned as negative.No residues in patient.

• Brand Name: AUTOMATIC VALVE, SIZE 12 MM
• Common Device Name: AUTOMATIC VALVE, SIZE 12 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 23595740
• Report Number: 2020550-2025-02111
• Device Sequence Number: 16047356
• Product Code: GCJ
• UDI-Device Identifier: 04048551118023
• UDI-Public: 04048551118023
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• 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): 11/19/2025
• Report Date (Section F): 11/19/2025

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 Number: 30104A1
• Device Catalogue Number: 30104A1
• Device Lot Number: LK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown