MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 0°, 5.5 MM, 50 CM

Model Number	R26048ASA
Medical Device Problem Codes	Leak/Splash (1354); Melted (1385); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
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 (b)(4).
Event or Problem Description
It was reported that the image is blurred and dark.Cannot adequately see tissue.No negative impact in state of health reported.
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
Investigation result: the system tube (shaft) of the optics is bent.Cracks and broken rod lenses are visible in the rod lens system.The image is blurred and foggy due to the broken rod lenses.The distal end is chemically damaged but intact.Residues are visible behind the distal cover glass, which are attributable to mechanical overload (over bending) of the shaft and the broken rod lenses.The damage found cannot be attributed to a manufacturing/production defect.The optical shaft was subjected to mechanical overload (excessive bending), which resulted in the breakage of one or more rod lenses.This has a negative impact on imaging.This event is filed under internal complaint id (b)(4).

• Brand Name: HOPKINS TELESCOPE 0°, 5.5 MM, 50 CM
• Common Device Name: HOPKINS TELESCOPE 0°, 5.5 MM, 50 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: 22777159
• Report Number: 9610617-2025-01402
• Device Sequence Number: 9488108
• Product Code: GCJ
• UDI-Device Identifier: 04048551314661
• UDI-Public: 04048551314661
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/21/2026

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: R26048ASA
• Device Catalogue Number: R26048ASA
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 01/14/2026
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/29/2025; 01/21/2026
• 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