MAUDE Adverse Event Report: KARL STORZ SE & CO.KG HOPKINS TELESCOPE 30°, 4 MM, 18 CM

Model Number	7230BVA
Medical Device Problem Codes	Break (1069); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
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 id (b)(4).
Event or Problem Description
It was reported that the hopkins scope was black / cannot see anything.No negative impact in state of health reported.
Additional Manufacturer Narrative
Conclusion summary: the device was sent to the karl storz assessment and repair department for inspection.During the technical inspection, the error description provided by the customer, "black / cannot see anything", could be confirmed.The examination revealed a broken lens system.Imaging is no longer possible due to the breakage.No further external damage is apparent.It is possible that the optics were subjected to mechanical overload, leading to the breakage of one or more imaging lenses.The damage is not attributable to a manufacturing or production fault.Analysis of the period in question, from (b)(6) 2023 - (b)(6) 2026, revealed a rate of (b)(4) based on total sales of (b)(4) units and one (1) complaint regarding this fault.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°, 4 MM, 18 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 4 MM, 18 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: 24078820
• Report Number: 9610617-2026-00054
• Device Sequence Number: 5790000
• Product Code: EOB
• UDI-Device Identifier: 04048551193914
• UDI-Public: 04048551193914
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K945788
• 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
• Report Date (Section B): 04/10/2026

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: 7230BVA
• Device Catalogue Number: 7230BVA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown