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

Model Number	UP210
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
Event or Problem Description
It was reported that the endomat select didn't have adequate suction during a procedure.The procedure could not be continued and the case was suspended.No death or (unanticipated) serious deterioration in state of health reported.Since the surgery was suspended, the case is deemed as reportable.

• 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: 18857846
• Report Number: 2020550-2024-00060
• Device Sequence Number: 14284119
• Product Code: HIG
• UDI-Device Identifier: 04048551376041
• UDI-Public: 4048551376041
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/07/2024
• Report Date (Section F): 03/07/2024

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: 03/06/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2024
• 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: Other
• Patient Sex: Unknown