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

Model Number	26605AA
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
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 while in radical hysterectomy surgery, system gave an "endoscope communication error" and immediately after the image flipped on its own in the original position and the error cleared on its own.Surgeon had to flip the image back in order to go back to the view surgeon was using before the error occurred.It was also reported that at the end of the procedure, after turning off the system, the operating room team interface (orti) displayed a screen with password requested.Start-up specialist (sus) turned off the lower uninterrupted power supply (ups) to completely shut down the system, the password screen was cleared, then turned on the lower ups and the system booted up on itself without using the power button.The patient was under anesthesia and in the operating room (or) when the issue occurred.No patient injury was reported.There was 1 minute delay in the procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: based on the customer's description of the error, our own experience and the investigation of other complaints with similar error patterns, the most likely cause could be a component problem in an accessory device.However, no information is available about other devices used.Regarding the tipcam itself, we were informed from the customer, that it is still in use.This suggests that the product can still be used as intended and is free of defects.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 avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21644469
• Report Number: 9610617-2025-00462
• Device Sequence Number: 7713504
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 09/30/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/17/2025; 10/20/2025
• 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