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

Model Number	27005BGA
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
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 (b)(4).
Event or Problem Description
It was reported the scope had blurry image.No negative impact in state of health reported.
Additional Manufacturer Narrative
Corrections in sections e1 contact name, d9 added date and h6 updated adverse event code e to 4582.This event is filed under internal complaint id: (b)(4).
Additional Manufacturer Narrative
Conculsion summary: the customer's statement blurry image can be confirmed.During the examination of the optics, moisture was found to have penetrated the rod lens system.The moisture has a negative effect on the image quality.Furthermore, foreign particles were found in the system.As there was no external damage that could have indicated a leak in the optics, the optics were subjected to a vacuum test.This revealed a leak in the area between the eyepiece bridge and the base housing.The leak is due to a manufacturing defect that was not detected during product testing but may have led to the leak after a few clinical reprocessing cycles.Improper cementing around the joint can lead to such a leak.This is an isolated case.No further measures will be taken.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.This event is filed under internal complaint (b)(4).

• Brand Name: GREENLIGHT HOPKINS TELESCOPE 30°, 4 MM
• Common Device Name: GREENLIGHT HOPKINS TELESCOPE 30°, 4 MM
• 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: 21944692
• Report Number: 9610617-2025-00757
• Device Sequence Number: 9056504
• Product Code: FAJ
• UDI-Device Identifier: 04048551288740
• UDI-Public: 04048551288740
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/24/2026

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: 27005BGA
• Device Catalogue Number: 27005BGA
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: Not provided; 02/08/2026
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/08/2025; 02/24/2026
• 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