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

Model Number	26605AA
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Optical Problem (3001); Prophylactic removal due to corrective action (4077)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the beginning/start of the procedure, after plugging in the tipcam it showed lines on monitor, causing the image not be come unclear.Second tipcam was used to complete the procedure.No negative impact in state of health reported.No harm to user or patient.
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).
Additional Manufacturer Narrative
The device was returned to the manufacturing site as documented in section d9.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Device evaluation: a visual and functional test was carried out on the endoscope.The handle and the shaft are scratched.The causes of the scratches are due to wear and tears.The error described by the customer " tipcam not functioning " could not be confirmed.The tipcam is fully functional.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production-related quality checks were passed, and no non-conformities were identified in the devices manufacturing records.The malfunction experienced by the customer is not attributable to the tipcam.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
• MDR Report Key: 23073963
• Report Number: 9610617-2025-01627
• Device Sequence Number: 9997156
• Product Code: FGB
• UDI-Device Identifier: 04048551347782
• UDI-Public: 04048551347782
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 05/21/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 04/16/2026; 05/20/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/20/2025; 04/16/2026; 05/21/2026
• 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