MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 2.7 MM, 18 CM

Model Number	28719BA
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Dent in Material (2526); Scratched Material (3020)
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 during cleaning it was noticed, that the shaft of the scope is loose.The technical inspection revealed that the shaft was ragged and light fibers and rod lenses were broken.No negative impact in state of health reported.
Additional Manufacturer Narrative
Investigation: accordingly, we would like to give a summary of our results regarding the reported issue.During the technical inspection of the returned device, the error description provided by the customer, " shaft of the scope is loose ", could be confirmed.During the technical inspection of the optics, a broken shaft was identified.The shaft itself shows significant bending, which is attributable to mechanical overload and ultimately led to it breaking off completely.The damage identified was not caused by a manufacturing or production fault but was caused by mechanical overload of the shaft.The event is filed under internal karl storz complaint id:(b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 2.7 MM, 18 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 2.7 MM, 18 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: 24264937
• Report Number: 9610617-2026-00172
• Device Sequence Number: 10021908
• Product Code: HRX
• UDI-Device Identifier: 04048551113189
• UDI-Public: 04048551113189
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K943052
• 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): 04/21/2026

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: 28719BA
• Device Catalogue Number: 28719BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/21/2026
• 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