MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 0°, 10 MM, 31 CM

Model Number	26003AA
Medical Device Problem Codes	Use of Device Problem (1670); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that both scopes were needed to be changed during the procedure as the light fibres were burnt and so not enough light efficiency to operate.No negative impact in state of health reported.
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
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id: (b)(4).
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
Result of investigation: 26003aa - hopkins optik 0°, 10 mm, 31 cm - lot 12026b unauthorized third-party repair, replacement eyepiece funnel with proximal cover glass installed in deviation from the kalr storz specification, surface deviating from the valid specification, foreign kit residue on the base housing, multiple broken optical fibres, damaged eyepiece funnel, moisture in the rod lens system.The optics in our possession show clear signs of unauthorized third-party repair.Contrary to the specification, the surface is not sandblasted but polished, the 0° position is off-center.Contrary to the valid specification, a third-party eyepiece funnel with proximal cover glass was installed.Most of the light guides are broken.The imaging is adequate but shows clear foreign particles and moisture in the system.All damage/impairments found are not due to a manufacturing/production defect, but were caused, among other things, by the third-party repair not authorized by karl storz.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 0°, 10 MM, 31 CM
• Common Device Name: HOPKINS TELESCOPE 0°, 10 MM, 31 CM
• 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 avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21633000
• Report Number: 9610617-2025-00452
• Device Sequence Number: 9246158
• Product Code: GCJ
• UDI-Device Identifier: 04048551090367
• UDI-Public: 04048551090367
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K223923
• 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): 05/19/2025

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: 26003AA
• Device Catalogue Number: 26003AA
• Device Lot Number: 12026B
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 03/24/2025; 05/08/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/17/2025; 04/17/2025; 05/19/2025
• 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