MAUDE Adverse Event Report: KARL STORZ SE & Co. KG UNIDRIVE S III Motor System

Model Number	20701020-1
Medical Device Problem Codes	Output Problem (3005); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: the patient underwent hysteroscopy.Equipment failure occurred during the procedure, resulting in inability to complete the surgery.The equipment has been taken out of service and returned for repair.No harm was caused to the patient.
Additional Manufacturer Narrative
Under user's discretion the device in question will not be returned to the manufacturer for evaluation.The investigation will be performed by a designated karl storz employee, investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: UNIDRIVE S III Motor System
• Common Device Name: UNIDRIVE S III Motor System
• 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: theresa mussaw ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 50352083
• Report Number: 9610617-2026-02002
• Device Sequence Number: 17658323
• Product Code: HIH
• UDI-Device Identifier: 04048551278802
• UDI-Public: 04048551278802
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/24/2026

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: 20701020-1
• Device Catalogue Number: 20701020-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown