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

Model Number	26605BA
Medical Device Problem Codes	Poor Quality Image (1408); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: "shadow and blurred image".No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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).
Additional Manufacturer Narrative
Accordingly, we would like to give a summary of our results regarding the reported issue.The evaluation results: the device was sent to the karl storz assessment and repair department for inspection.During the technical inspection, the error description provided by the customer, "shadow and blurred image", could be confirmed.During the technical inspection, the fault description provided by the customer, shadows and blurred image,' was confirmed.During the inspection of the optics based on the customer's description, shadows and poor image quality were found as described, which can be attributed to a possible defect in an optical component (image sensor).Visible residues in the image indicate faulty image sensors.Due to the design of the tipcam, the cause can only be analyzed by dismantling the device, which would cause further damage.We therefore assume that a component is defective and classify this as a production fault.In addition, there are scratches on the surface of the handle, which are due to use and processing.The above 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 device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.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: 24211012
• Report Number: 9610617-2026-00170
• Device Sequence Number: 15868521
• Product Code: FGB
• UDI-Device Identifier: 04048551347843
• UDI-Public: 04048551347843
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/17/2026

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: 01/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown