MAUDE Adverse Event Report: KARL STORZ SE & Co. KG TIPCAM1 S 3D LAP, 0°

Model Number	26605AA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a prostatectomy, there was an endoscope failure error.The endoscope module was restarted each time with about 1 hour of delay because after some time it appeared again.The endoscope was continued to be used.There was no patient injury.The procedure was completed successfully.
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).

• Brand Name: TIPCAM1 S 3D LAP, 0°
• Common Device Name: TIPCAM1 S 3D LAP, 0°
• Manufacturer (Section D): KARL STORZ SE & Co. KG; dr.-karl-storz-strasse 34; tuttlingen 78532
• MDR Report Key: 50150332
• Report Number: 50150332
• Device Sequence Number: 9261465
• Product Code: FGB
• UDI-Device Identifier: 04048551347782
• UDI-Public: 04048551347782
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2026
• Report Date (Section F): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown