MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ASM, HEAD, H1

Model Number	TH130
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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
It was reported that the camera head failed during laparoscopy.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Investigation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer, "failed during laparoscopy", could be confirmed.The cause can be attributed to a random defect of the camera head cable.The shielding of the cable is broken and thus the hf radiation can influence the signal wires.Consequently, the image flickers or disappears during hf treatment.According to the ifu visual as well as functionality should always be checked before every use to avoid injuries and damages to the product.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ASM, HEAD, H1
• Common Device Name: ASM, HEAD, H1
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo
• MDR Report Key: 23659219
• Report Number: 2027009-2025-02153
• Device Sequence Number: 13292814
• Product Code: GCJ
• UDI-Device Identifier: 04048551425664
• UDI-Public: 04048551425664
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K222504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TH130
• Device Catalogue Number: TH130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown