MAUDE Adverse Event Report: KARL STORZ ENDOVISION HOPKINS TELESCOPE 0°, 5 MM, 29 CM

Model Number	R26046AA
Medical Device Problem Codes	Dent in Material (2526); Chemical Problem (2893); Material Deformation (2976); Optical Distortion (3000); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
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 (b)(4).
Event or Problem Description
It was reported that there was a cloudy image.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device was returned june 12, 2025, and 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).
Additional Manufacturer Narrative
During the examination, a bent shaft was detected.In the shaft a dent is visible.Due to the impact points at the distal tip, particles are visible in the rod lens system.The distal solder seam is clearly chemically attacked and leaking.The image is cloudy and blurred due to the infiltrated moisture that has penetrated through the chemically damaged solder seam.The damage found cannot be attributed to a manufacturing/production fault.Likely, the damage was caused during clinical use or clinical reprocessing.No further measures will be taken.The above conducted 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 devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pick up in similar complaints, no trend was identified.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 ENDOVISION; 91 carpenter hill road; charlton, ma 01507 ; GM 01507
• 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: 22126476
• Report Number: 9610617-2025-00958
• Device Sequence Number: 20704068
• Product Code: GCJ
• UDI-Device Identifier: 04048551092088
• UDI-Public: 04048551092088
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/17/2025

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: R26046AA
• Device Catalogue Number: R26046AA
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 10/02/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/16/2025; 10/17/2025
• 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