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

Model Number	27005CA
Medical Device Problem Codes	Fogging (1253); Residue After Decontamination (2325); Dent in Material (2526); Optical Problem (3001); Optical Obstruction (3002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to manufacturer on april 25, 2025.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).
Event or Problem Description
It was reported that vision was not clear.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the conducted investigations did not reaveal 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 pick up in similar complaints, no trend was identified.The following damage was found during the inspection: the distal solder joint is chemically corroded and leaking.There are residues on the distal cover glass.The shaft is mechanically crushed.Moisture in the rod lens system.The customer's statement "trüb (blurred)" can be confirmed.There are unknown residues of unknown origin adhering to the distal cover glass.The distal solder joint is chemically corroded and partially detached in one area, causing a leak.The leak in the solder joint allowed moisture to penetrate the rod lens system unimpeded, contributing to the blurring of the image.The shaft shows a clear mechanically caused dent.The residues could be cleaned with alcohol and polishing paste.Furthermore, clearly visible residues/abrasion are visible in the rod lens system.The damage found cannot be attributed to a manufacturing/production defect but was most likely caused by clinical use/reprocessing.No further measures will be taken.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: 22030381
• Report Number: 9610617-2025-00861
• Device Sequence Number: 8112082
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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