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

Model Number	26605AA
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
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 a partial nephrectomy robotic laparoscopic procedure, after 3 minutes into the case, the surgeon lost the endoscope feed.It was found that the data cable of the endoscope snapped.The endoscope was replaced with a new one and the surgery was continued.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device was not sent to the karl storz assessment and repair department for inspection.The error description provided, " endoscope cable snapped during use ", could not be confirmed.It is not possible to carry out a detailed technical investigation solely based on the description, as the product has not been made available to us for a more detailed technical analysis.Therefore, an analysis based on the customer's information cannot be carried out.The considered information / data did not reveal any root cause related to the labelling, the device, or its history.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: 24474818
• Report Number: 9610617-2026-00390
• Device Sequence Number: 15793007
• Product Code: FGB
• UDI-Device Identifier: 04048551347782
• UDI-Public: 04048551347782
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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): 04/14/2026

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
• Device Lot Number: 12527
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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