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

Model Number	26605AA
Medical Device Problem Codes	Use of Device Problem (1670); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
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 the last 5 minutes of a robotic laparoscopic procedure, the image from the scope briefly flickered for a few moments when the monopolar was activated.The team proceeded to complete the surgery.After the procedure, when the endoscope was disconnected from the robotic arm but the cables were still connected to the storz system, the image completely disappeared, leaving only purple and white flashes on the screen.The start-up specialist (sus) unplugged and replugged the black cable, which triggered a red alarm stating frozen endoscope.Subsequently, the black cable was unplugged from the storz system again, resulting in a yellow alarm stating endoscope was not supported.The sus replaced the endoscope with a different one, and no further issues were observed.There was no patient injury.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device was returned on 13aug2025 device investigation completed on 27nov2025 result of investigation: the investigation revealed the following errors: the handle is scratched.The shaft is scratched.The technical investigation did not reveal the fault described by the customer ("image completely disappeared during use").Only scratches on the shaft and handle were found.As this was a robot-assisted operation, there could also be a connection fault between the devices.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
• MDR Report Key: 22741167
• Report Number: 9610617-2025-01386
• Device Sequence Number: 21142267
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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
• Patient Sex: Unknown