MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 0°, 5 MM, 29 CM

Model Number	HOPKINS TELESCOPE 0°, 5 MM, 29 CM
Medical Device Problem Codes	Fracture (1260); Chemical Problem (2893); Material Deformation (2976); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for 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 was reported the scope had blurry image during the medical procedure no negative impact to the patient reported.
Additional Manufacturer Narrative
Correction in section g3 aware date has been added april 7,2025.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Conclusion: due to the bent shaft, a chip occurred in the edge area of a rod lens in the rod lens system.Due to the chip, glass particles and other dirt particles are visible in the rod lens system.The distal solder seam is clearly chemically corroded and leaking.The image is cloudy and blurred on the right-hand edge due to the spalling and moisture that has penetrated through the chemically damaged solder seam.The damage found cannot be attributed to a manufacturing/production fault.Most probable the damage was caused during clinical use or clinical reprocessing.This event is filed under internal complaint id_(b)(4).

• Brand Name: HOPKINS TELESCOPE 0°, 5 MM, 29 CM
• Common Device Name: HOPKINS TELESCOPE 0°, 5 MM, 29 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: 21853204
• Report Number: 9610617-2025-00645
• Device Sequence Number: 7953767
• Product Code: GCJ
• UDI-Device Identifier: 04048551092088
• UDI-Public: 04048551092088
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K935279
• 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
• Report Date (Section B): 11/20/2025

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: HOPKINS TELESCOPE 0°, 5 MM, 29 CM
• Device Catalogue Number: HOPKINS TELESCOPE 0°, 5 MM, 29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 11/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/02/2025; 11/20/2025
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Weight: 101 KG