MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MYOMEN INSTRUMENT

Model Number	26175B
Medical Device Problem Codes	Break (1069); Material Separation (1562)
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.This information is reflected in section d9.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
The following was reported: the end of the instrument has broken off and is missing.The customer was made aware but was unable to confirm where this could have happened.No negative impact in state of health reported.However, due to the missing part, this malfunction is being reported as a precautionary measure.
Additional Manufacturer Narrative
During the manufacturer's technical inspection, the error description provided by the customer, "piece broke off and is missing", could be confirmed.The spiral at the distal end has broken off.This damage is the result of mechanical overload.Based on the age of the item (manufacturing date: 2016-01-15) and the presumed number of uses, a manufacturing defect can be ruled out.The investigation did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MYOMEN INSTRUMENT
• Common Device Name: MYOMEN INSTRUMENT
• 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: 22939386
• Report Number: 9610617-2025-01523
• Device Sequence Number: 13241623
• Product Code: HET
• UDI-Device Identifier: 04048551099001
• UDI-Public: 04048551099001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K945211
• 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): 01/19/2026

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: 26175B
• Device Catalogue Number: 26175B
• Device Lot Number: NT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 01/19/2026
• 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