MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 5 MM, 24 CM

Model Number	50251BA
Medical Device Problem Codes	Leak/Splash (1354); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the image was foggy at the corner.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: during the inspection of the optics, a mechanical impact mark/deformation was found in the distal area at the edge of the solder seam.Furthermore, a leak was detected between the eyepiece bridge and the base housing during the vacuum test.The image is blurred due to moisture penetration in the edge area.The customer's information can be confirmed.The optics appear cloudy and blurred at the edges.When examining the individual rod lens segments in the system tube, moisture was detected.Since the slight mechanical damage to the distal solder seam could not be held responsible for this, the optics were subjected to a vacuum test.This revealed a leak at the connection between the eyepiece bridge and the base housing.No further damage was found on the optics.The leak can be attributed to a failure of the adhesive bond between the two components applied at the factory.The leak allowed moisture to enter the system, which had a negative effect on the image quality.This is an isolated fault.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 pickup in similar complaints, no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 5 MM, 24 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 5 MM, 24 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22046614
• Report Number: 9610617-2025-00881
• Device Sequence Number: 12957190
• Product Code: GCJ
• UDI-Device Identifier: 04048551171356
• UDI-Public: 04048551171356
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: 50251BA
• Device Catalogue Number: 50251BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 09/12/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown