MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOMAT SELECT

Model Number	UP210
Medical Device Problem Codes	Output Problem (3005); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported: "on (b)(6) 2026 at 09:00, in operating room 3, the patient underwent hysteroscopy and endometrial lesion resection under general anesthesia.During the procedure, while using the gynecological shaver, the endoscopic irrigation and suction device experienced a display interface malfunction, preventing navigation to the next screen and failing to aspirate tissue normally.The device was immediately powered off and restarted, and maintenance personnel were notified.After the restart, the device returned to the normal interface but subsequently triggered a fault alarm again.The physician changed the specimen collection method, manually using a suction canister to aspirate the tissue.".

• Brand Name: ENDOMAT SELECT
• Common Device Name: ENDOMAT SELECT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 25126033
• Report Number: 2020550-2026-01026
• Device Sequence Number: 10729204
• Product Code: HIG
• UDI-Device Identifier: 04048551376041
• UDI-Public: 04048551376041
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2026
• Report Date (Section F): 05/08/2026

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: UP210
• Device Catalogue Number: UP210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/28/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown