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

Model Number	26605AA
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183); Adverse Event Without Identified Device or Use Problem (2993); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robotic laparoscopic radical prostatectomy procedure, the image was lost momentarily, as if it had restarted.When the team attempted to virtually reverse the image, the endoscope buttons did not respond and stopped functioning.The team unplugged and reconnected the communication cable of the endoscope, which restored the image.However, the endoscope buttons remained non-functional.The team manually rotated the camera to resolve the issue.This resulted in a 10-minute delay.There was no patient injury.No negative impact in state of health reported.Cross reference mdr: 9610617-2025-01175.
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).
Additional Manufacturer Narrative
The devices concerned (tc302 - image1 s d3-link, serial# (b)(6) and 26605aa - tipcam 1 s 3d lap, 0°, serial# (b)(6)) were not returned to the manufacturer for inspection.Therefore, a physical technical inspection was not possible, and a precise error analysis could not be carried out.The investigation could only be performed based on the available event information, which states that "during a robotic laparoscopic radical prostatectomy procedure, the image was lost momentarily, as if it had restarted.When the team attempted to virtually reverse the image, the endoscope buttons did not respond and stopped functioning.The team unplugged and reconnected the communication cable of the endoscope, which restored the image.However, the endoscope buttons remained non-functional.The team manually rotated the camera to resolve the issue.This resulted in a 10-minute delay.There was no patient injury." furthermore, the customer provided a photo of an error message which states that there was an endoscope failure.Based on the error message it is concluded that the device tc302 was not causative, because the error message indicates an endoscope error.As stated, a precise error analysis is not possible without the devices and according to the event information it is possible that the 26605aa tipcam camera was not primarily responsible for the system failure, as the camera, in combination with a computer-controlled robotic arm, forms a system network that failed for reasons which are not known.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: 22482394
• Report Number: 9610617-2025-01176
• Device Sequence Number: 8554472
• Product Code: FGB
• UDI-Device Identifier: 04048551347782
• UDI-Public: 04048551347782
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 06/23/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 03/16/2026
• 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