MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 70°, 4 MM

Model Number	27005CA
Medical Device Problem Codes	Dent in Material (2526); Improper Chemical Reaction (2952); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device shows problems with the optical system.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the optical examination revealed impact marks on the shaft and at the distal end.The solder joint has been chemically corroded and partially dissolved.Residues or a coating can be seen on the distal cover glass.The customer's statement regarding "poor vision" can be confirmed.An unknown coating/residue can be seen on the distal cover glass, which can be wiped off with an alcohol solution.The coating negatively affects the imaging and causes the image to appear cloudy in places.Various mechanical damage in the form of scratches or impact marks can be seen on the distal end and on the shaft.The distal solder joint has been chemically attacked and is partially dissolved.In the rod lens system itself, abrasion/foreign particles can be detected when focusing through the individual segments.The cloudy/blurred imaging is due to the coating on the distal cover glass.The defects/damage found are not due to a manufacturing/production error but may have been caused during clinical use/clinical reprocessing.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 70°, 4 MM
• Common Device Name: HOPKINS TELESCOPE 70°, 4 MM
• 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: 22845357
• Report Number: 9610617-2025-01441
• Device Sequence Number: 17369112
• Product Code: FAJ
• UDI-Device Identifier: 04048551001073
• UDI-Public: 04048551001073
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 27005CA
• Device Catalogue Number: 27005CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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
• Patient Sex: Unknown