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
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).
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 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
Additional information is provided in szection d4.Result of investigation: 26003aa - hopkins optik 0°, 10 mm, 31 cm - lot 1204xa.During the examination of the optics, air bubbles were detected in the silicone separating layer of the distal cover glass.The distal end shows scratches (13 years old) and normal signs of wear and tear.Abrasion/foreign particles and moisture are visible in the rod lens system.The light-conducting fibers are severely burnt and severely restricted in light transmission.The customer's statement [?]light fibers were burnt' can be confirmed.The optical light-conducting fibers are severely thermally damaged, which severely restricts the illumination of the field of view.Despite the age of the optics (13 years), the imaging can still be described as excellent.The brilliance and image sharpness are very good.The entire optics show normal signs of wear and are in very good overall condition for their age.Mechanical damage such as scratches and impact marks are visible at the distal end, which may be responsible for the air bubbles in the silicone separating layer of the optics.This damage may have been caused by mechanical damage (impact).Furthermore, foreign particles, abrasion and moisture are visible in the rod lens system.The existing damage was caused by clinical use/clinical processing and cannot be attributed to a manufacturing/production defect.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: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21632995
• Report Number: 9610617-2025-00456
• Device Sequence Number: 9246156
• 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
• 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: 1204XA
• 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: 03/24/2025; 05/08/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/22/2025; 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