MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, ROTATABLE, FOR 26050SL

Model Number	26050XA
Medical Device Problem Codes	Break (1069); Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025 during a hysteroscopy procedure the ceramic beak tip of 26fr innersheath broke off in the patient.Piece was recovered.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device was returned to our us facility on february 17, 2025.It 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).
Additional Manufacturer Narrative
Per inventigation by the manufacturing site: the most probable root cause of the ceramic tip breaking is user error due to external force.Due to the age and the assumed number of applications and preparations, wear (changes in material properties) cannot be ruled out either.This event is filed under internal complaint id (b)(4).

• Brand Name: INNER SHEATH, ROTATABLE, FOR 26050SL
• Common Device Name: INNER SHEATH, ROTATABLE, FOR 26050SL
• 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 92344 ; 4242188247
• MDR Report Key: 21402237
• Report Number: 9610617-2025-00252
• Device Sequence Number: 8523620
• Product Code: HIH
• UDI-Device Identifier: 04048551092668
• UDI-Public: 04048551092668
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K221893
• 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
• Report Date (Section B): 05/28/2025

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: 26050XA
• Device Catalogue Number: 26050XA
• Device Lot Number: SY02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female