MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH RESECTOSCOPE SHEATH,22CHARR

Model Number	26055CB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following information was received: during tcrf loop broke inside patient, the bipolar cut was then activated causing a spark and burn/crack to the ceramic beak on sheath.Dark charred marks were noted on fibroids however customer swapped set and carried on resection as normal, at the end of the procedure the dark marks were no longer present.The broken part was retrieved from the patient.No negative impact in state of health reported.The following information was received: during tcrf loop broke inside patient, the bipolar cut was then activated causing a spark and burn/crack to the ceramic beak on sheath.Dark charred marks were noted on fibroids however customer swapped set and carried on resection as normal, at the end of the procedure the dark marks were no longer present.The broken part was retrieved from the patient.No negative impact in state of health reported.Cross reference mdr 9610617-2026-00674.
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).

• Brand Name: INNER SHEATH RESECTOSCOPE SHEATH,22CHARR
• Common Device Name: INNER SHEATH RESECTOSCOPE SHEATH,22CHARR
• 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: 24708742
• Report Number: 9610617-2026-00673
• Device Sequence Number: 10467262
• Product Code: HIH
• UDI-Device Identifier: 04048551275597
• UDI-Public: 04048551275597
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 26055CB
• Device Catalogue Number: 26055CB
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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