MAUDE Adverse Event Report: KARL STORZ SE & CO.KG HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM

Model Number	R26120BA
Medical Device Problem Codes	Break (1069); Decoupling (1145); Inadequate or Insufficient Training (1643); Dent in Material (2526); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturer for further investigation.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It has been reported: major damage, exposed light fibers on light post.The light hooks broke off from the scope no negative impact in state of health reported.
Additional Manufacturer Narrative
The device will not be forwarded to the manufacturer for further investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
The device will be forwarded to the manufacturer for further investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Correction made in section d2b.The correct code is hih.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Product evaluation: the examination revealed scratches/impact marks on the shaft surface.The shaft is slightly bent.There are unknown residues adhering to the distal cover glass.The light connector is torn off and the light connector adapter is missing.Foreign bodies are visible in the rod lens system.The damage found cannot be attributed to a manufacturing/production defect.The damage was caused by improper handling during clinical use/clinical reprocessing.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.This event is filed under internal complaint id (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM
• Manufacturer (Section D): KARL STORZ SE & CO.KG; dr.karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 23514632
• Report Number: 9610617-2025-02042
• Device Sequence Number: 21320865
• Product Code: HIH
• UDI-Device Identifier: 04048551093832
• UDI-Public: 04048551093832
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K943176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/13/2026

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: R26120BA
• Device Catalogue Number: R26120BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 10/27/2025; 02/12/2026; 03/09/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/14/2025; 11/18/2025; 02/18/2026; 03/13/2026
• 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