MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM 1 S 3D LAP, 30°

Model Number	26605BA
Medical Device Problem Codes	Corroded (1131); Erratic or Intermittent Display (1182); Output Problem (3005); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that sporadic image disappears after movement / light dims.Camera does not connect to lsk tower.Message: head is incompatible.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information reflected in section b5.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Additional information received on june 17,2025." only the icg function has failed.Not the image.Therefore, no damage.".
Additional Manufacturer Narrative
Device evaluation: during the inspection of the product concerned, a value of 67% of 100% was determined in relation to the total light output.The light guides are chemically corroded.Furthermore, corrosion was detected on the connection plug.Based on the optical condition of the connection plug, it can be concluded that there has been a lack of maintenance/care, which may be responsible for the failure of the icg function reported by the customer.The handle and shaft show mechanical damage in the form of scratches.It is concluded that the defects found are not due to a manufacturing or production error but were caused by clinical use/clinical reprocessing.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TIPCAM 1 S 3D LAP, 30°
• Common Device Name: TIPCAM 1 S 3D LAP, 30°
• 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: 22167187
• Report Number: 9610617-2025-00946
• Device Sequence Number: 18090081
• Product Code: FGB
• UDI-Device Identifier: 04048551347843
• UDI-Public: 04048551347843
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 02/23/2026

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: 26605BA
• Device Catalogue Number: 26605BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 02/02/2026
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/15/2025; 02/23/2026
• 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