MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HYSTEROSCOPE SHEATH, 5 MM; Hysteroscope (And Accessories)

Model Number	R26153EA
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	Malfunction
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 received 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
It is unknow 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 physican was trying to get theproduct 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: 9610617-2025-00026.
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 breakage of the guide tube is a consequence of the bent optics.Since the age is unknown, the shaft may show signs of wear and tear.This can also change the material properties.For example, attempting to bend the shaft back may also cause it to break.Since the main cause can be traced back to the optics, the investigation focuses on the optical data.Cross reference complaint id: (b)(4).This event is filed under internal complaint id (b)(4).
Event or Problem Description
Cross reference mdr: 9610617-2025-00026.

• Brand Name: HYSTEROSCOPE SHEATH, 5 MM
• Common Device Name: Hysteroscope (And Accessories)
• 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: 21150664
• Report Number: 9610617-2025-00025
• Device Sequence Number: 21129635
• Product Code: HIH
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K223885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/17/2026

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: R26153EA
• Device Catalogue Number: R26153EA
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• 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; 09/04/2026
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/29/2025; 03/03/2025; 07/02/2025; 09/18/2026
• 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