MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM

Model Number	R26120BA
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device will be returned to the manufacturing site for investigation.In the event the device returns and relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference complaint id: (b)(4).This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported during a medical procedure on (b)(6) 2024, the physician was trying to get the product through the cervix and the scope broke.The hysteroscope sheath and hopkins telescope 30°, 2.9 mm, 30 cm were attached (both instruments were being used during the procedure).It was not reported if there was any harm to the patient.No additional information was provided after multiple attempts.Cross reference mdr: 9610617-2025-00025.
Event or Problem Description
Additional information: it was reported during the hytersocopy procedure was prolonged for 30 minutes on (b)(6) 2024, the surgeon was not able to complete the procedure, the patient was referred to gyn.
Additional Manufacturer Narrative
Additional information recevied reflected on adverse event, in section b1, b5 and in section h1.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned on february 19,2025 for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the optical shaft is severely bent, resulting in one or more rod lenses being broken and imaging no longer possible.The damage was caused by excessive mechanical bending stress, which led to total failure of imaging and destruction of the optics.The damage cannot be attributed to a manufacturing/production defect.Cross reference complaint id: (b)(4).This event is filed under internal complaint id (b)(4).
Event or Problem Description
Cross reference mdr: (b)(4).
Additional Manufacturer Narrative
Correction made in section d2b.The correct code is hih.This event is filed under internal complaint id (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21150654
• Report Number: 9610617-2025-00026
• Device Sequence Number: 9189863
• Product Code: HIH
• UDI-Device Identifier: 04048551093832
• UDI-Public: 04048551093832
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: R26120BA
• Device Catalogue Number: R26120BA
• Device Lot Number: 1216S2
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 01/17/2025; 02/19/2025; 06/16/2025; 02/12/2026
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/29/2025; 03/03/2025; 07/02/2025; 02/18/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown