MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA. INC HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM

Model Number	R26120BA
Medical Device Problem Codes	Device Reprocessing Problem (1091); Corroded (1131); Detachment of Device or Device Component (2907); Material Deformation (2976); Optical Problem (3001); Failure to Clean Adequately (4048); Poor Visibility (4072)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
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 that the scope had error message and blurry image that delayed the case for 45 minutes.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the examination of the optics reveals a break in the light adapter with heavy unknown residue and deposits.The optics shaft is bent and has a dent.The distal solder seam is severely corroded.There is unknown residue on the distal cover glass, which negatively affects imaging.The light adapter itself shows signs of overload breakage at the edge.The customer's statement "the scope had error message and blurry image" can be confirmed.Examination of the optics reveals a break in the light adapter with heavy unknown residue and adhesions.The optics shaft is bent and has a dent.The distal solder seam is severely chemically corroded.There is unknown residue on the distal cover glass, which negatively affects imaging.The light adapter itself shows signs of overload breakage at the edge.The optics show heavy signs of wear and are in very poor condition.The damage found cannot be attributed to a manufacturing/production defect.Based on the examination results, the damage is attributable to clinical use and a lack of cleaning/care, as well as mechanical overload.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).

• 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 ENDOSCOPY-AMERICA. INC; 2151 e. grand avenue; el segundo CA 90245
• 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: 22321990
• Report Number: 9610617-2025-01092
• Device Sequence Number: 8987997
• Product Code: HIH
• UDI-Device Identifier: 04048551093832
• UDI-Public: 04048551093832
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: R26120BA
• Device Catalogue Number: R26120BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 02/12/2026
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/17/2025; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female