MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM 1 S 3D LAP, 30°

Model Number	26605BA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.Cross reference complaint id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that pre-operatively, as soon as the endoscope was connected, there was a red warning alarm: "the endoscope image is frozen".The endoscope was changed but still received the same error.The storz was rebooted but still the same error.The surgeon decided to convert to another robotic system.There was no harm to the patient.No negative impact in state of health reported.Cross refrence mdr: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the customer's statement "red warning alarm on the endoscope" cannot be confirmed.The device in question is used with a third-party product (medtronic).This device emits a "red alarm" that is not relevant to karl storz products.A precise error analysis cannot be carried out because the device has not been returned to us despite several written requests to the customer.There may be an electronic defect in a component that cannot be analysed at this time.If the optics are made available to us, the report will be reopened, and a root cause analysis will be carried out.In the corresponding ri tipcam 1 s 3d lap , 30° 26605ba_en_v59.3_04-2025_ri_ce, chapter 9 visual inspection among others the following is listed: check products for the following points: visible contamination, damage and corrosion, completeness, and dryness.To discard: damaged and corroded medical devices.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TIPCAM 1 S 3D LAP, 30°
• Common Device Name: TIPCAM 1 S 3D LAP, 30°
• 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, CA 90245
• MDR Report Key: 22039482
• Report Number: 9610617-2025-00874
• Device Sequence Number: 8899591
• Product Code: FGB
• UDI-Device Identifier: 04048551347843
• UDI-Public: 04048551347843
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2025

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: 26605BA
• Device Catalogue Number: 26605BA
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 12/01/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/24/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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