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

Model Number	26605AA
Medical Device Problem Codes	Optical Problem (3001); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
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.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during procedure, the endoscope image turned white and a danger error endoscope image blocked, check the endoscope system, if the error persist remove the instrument and stop using the system.Appeared on the surgeon console.Start-up specialist unplugged and replugged the cable back in the storz system and this resolve the issue.There was no injury reported to the patient.
Additional Manufacturer Narrative
Result of investigation: 26605aa - tipcam 1 s 3d lap, 0 (leading component): the customer's statement "image turned white - during use" cannot be confirmed.The error described by the customer could not be reproduced.It is possible that the tipcam failure was caused by an incorrectly seated connector or by liquid residue or contamination on the connector contacts.According to the customer, the problem was resolved immediately by disconnecting the tipcam from the imaging combination and reconnecting it immediately.According to the customer, the light cable used at the same time had no influence on the electrical failure/interruption of the imaging of the tipcam used.In our opinion, the cause of the fault described by the customer cannot be attributed to a production/manufacturing fault.Regarding the information in our reprocessing instructions ifu tipcam 1 s 3d lap,0°, version 26605aa_en_v37.2_08-2022_ri_ce under point 10.1 paragraph 7.And paragraph 8.Reference is made to the functional test before the actual application.Consequently, possible malfunctions related to the presence of residual liquid or residues on the connector could be avoided if these steps had been carried out before use.Furthermore, the light output is outside the specification < 40% and is not sufficient for accurate illumination.Mechanical damage is visible at the distal end.During inspection of the handle, mechanical damage in the form of scratches was found.Furthermore, there is damage/impact marks on the shaft.The software installed is outdated.At the time of inspection, a total operating time of 290.32 hours was read from the device.The damage found cannot be attributed to a manufacturing/production defect but was most likely caused during clinical use/clinical reprocessing.495vit - fiber optic light cable, 550 cm, ø4.8 mm (involved component): according to the customer, the light cable used at the same time had no influence on the electrical failure/interruption of the imaging of the tipcam used.Furthermore, the cable was not provided for investigation.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: 21369557
• Report Number: 9610617-2025-00200
• Device Sequence Number: 8472630
• 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
• Report Date (Section B): 07/14/2025

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
• Device Lot Number: 12636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 07/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE: 495VIT.
• Patient Sex: Unknown