MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 0°, 4 MM, 30 CM

Model Number	R27005AA
Medical Device Problem Codes	Break (1069); Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
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 complaint id (b)(4).
Event or Problem Description
It was reported that: the optic is completely black no patient injury and no negative impact reported.
Additional Manufacturer Narrative
The product has been returned on april 28, 2025 and will be sent to the manufacture for further evaluation.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 customer's statement that the optic is completely black can be confirmed.The optics are very blurred and out of focus.When focusing the optics, a broken rod lens system was detected.The breakage of the system was possibly caused by the bent shaft.The shaft may have been mechanically overloaded during clinical use or clinical reprocessing, resulting in the breakage of one or more rod lenses.Normal signs of wear, such as scratches, are visible on the shaft itself, which can be considered normal for the age of the optics (7 years).The overall condition of the optics is good.The damage found cannot be attributed to a manufacturing/production defect, but was probably caused by use/clinical reprocessing, as already mentioned.No further measures will be taken.This event is filed under internal complaint (b)(4).

• Brand Name: HOPKINS TELESCOPE 0°, 4 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 0°, 4 MM, 30 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: 21642188
• Report Number: 9610617-2025-00457
• Device Sequence Number: 7574605
• Product Code: FAJ
• UDI-Device Identifier: 04048551073070
• UDI-Public: 04048551073070
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 07/14/2025

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: R27005AA
• Device Catalogue Number: R27005AA
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 07/03/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/07/2025; 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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