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

Model Number	26048ASA
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that scope's picture was very blurry from the start of the case.It was confirmed that there was no patient injury / impact due to this and the procedure was completed successfully with another sterilized scope and a delay of 2 minutes.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
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
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, scope's picture was very blurry, could be confirmed.An examination of the optics revealed that one or more rod lenses in the system had burst.Residue and glass shards are visible when focusing.The distal solder joint is corroded.Residue is visible behind the distal cover glass.The damage observed was not caused by a manufacturing or production defect but is attributable to mechanical damage (excessive bending of the shaft) during clinical use or clinical reprocessing.The evaluation for the period from (b)(6) 2023 - (b)(6) 2026, revealed a rate of (b)(4) based on a total sales volume of (b)(4) units and six (6) complaints regarding this defect.No further measures will be taken.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 (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: 23854423
• Report Number: 9610617-2025-02387
• Device Sequence Number: 12032363
• Product Code: GCJ
• UDI-Device Identifier: 04048551314661
• UDI-Public: 04048551314661
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K223923
• 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): 04/17/2026

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: 26048ASA
• Device Catalogue Number: 26048ASA
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/15/2026; 04/15/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/26/2026; 04/17/2026
• 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