MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MINI STRAIGHT FORWARD TELESCOPE 0°,1.3MM

Model Number	11575A
Medical Device Problem Codes	Break (1069); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: "no image".No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
The device in question (11575a, mini straight forward telescope 0°,1.3mm, sn (b)(6), manufactured 21-february-2025) was received by the manufacturing site in germany on 29-oct-2025 for investigation.During the technical inspection, the error description provided by the customer, " no image ", could be confirmed.During the root cause analysis by the manufacturer, a broken image conductor tube was discovered.The break of the image conductor tube had a negative impact on imaging.The damage found is not attributable to a manufacturing defect.Such damage can be caused by clinical use/clinical reprocessing.No further measures will be taken.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.In addition, we would like to draw your attention to pages 3-19 of the corresponding reprocessing instructions ((b)(4) version v5.0 - 11/2017), which provide guidance on proper handling, including relevant warnings and cautions.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MINI STRAIGHT FORWARD TELESCOPE 0°,1.3MM
• Common Device Name: MINI STRAIGHT FORWARD TELESCOPE 0°,1.3MM
• 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: 23659241
• Report Number: 9610617-2025-02170
• Device Sequence Number: 21363302
• Product Code: GCJ
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K012527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/02/2026

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: 11575A
• Device Catalogue Number: 11575A
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 06/02/2026
• 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