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

Model Number	27005BA
Medical Device Problem Codes	Dent in Material (2526); Chemical Problem (2893); Material Deformation (2976); 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 the manufacturer.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 hopkins optics has bad image.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: during the technical inspection of the returned device, the error description provided by the customer, " bad image", could be confirmed.The examination revealed a bent shaft, which resulted in a chipping rod lens.As a result, increased abrasion and dirt particles are visible in the system.The distal solder joint is chemically corroded and leaking.Moisture is present in the rod system.The defects/damage found lead to blurred and cloudy imaging and are not attributable to a production/manufacturing defect.This damage is caused by improper handling/mechanical overload or by incorrect clinical reprocessing.This event is filed under internal complaint id (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 4 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 4 MM, 30 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: 23737229
• Report Number: 9610617-2025-02444
• Device Sequence Number: 15558825
• Product Code: FAJ
• UDI-Device Identifier: 04048551001066
• UDI-Public: 04048551001066
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K243653
• 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): 12/16/2025

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: 27005BA
• Device Catalogue Number: 27005BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown