MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM 1 S 3D LAP, 0°

Model Number	26605AA
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Defective Component (2292); Defective Device (2588); 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
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
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).
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 "endoscope red warning alarm" cannot be confirmed.The device mentioned is used with a third-party product (medtronic).This device emits a "red alert," which is not applicable to karl storz products.During the inspection of the optics, a defect in the connection cable was found.The defect is most likely related to a cut in the connection cable, which led to the malfunction of the device.As a result, electronic imaging is not possible.Furthermore, mechanical damage was found at the distal end, on the handle, and on the shaft.Likely, the damage was caused during clinical use/clinical reprocessing.In the corresponding ifu ri tipcam 1 s 3d lap , 0° 26605aa_en_v37.2_08-2022_ri_ce, chapter 9 visual inspection among others the following is listed: check products for the following points: - visible contamination - damage and corrosion - completeness - dryness and to discard - damaged and corroded medical devices.- incomplete medical devices or replace missing parts.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TIPCAM 1 S 3D LAP, 0°
• Common Device Name: TIPCAM 1 S 3D LAP, 0°
• 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: 22039481
• Report Number: 9610617-2025-00873
• Device Sequence Number: 12986455
• Product Code: FGB
• UDI-Device Identifier: 04048551347782
• UDI-Public: 04048551347782
• 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): 12/17/2025

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: 26605AA
• Device Catalogue Number: 26605AA
• 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; 12/17/2025
• 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