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

Model Number	UP210
Medical Device Problem Codes	Problem with Software Installation (3013); 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	Malfunction
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.
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).
Additional Manufacturer Narrative
Additional information is provided in section d4.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: during investigation of the claimed endomat select it was found, that only the license up602 is installed.This license does not include suction procedures.The root cause for this incident is the misunderstanding of the user what the endomat select could do, respectively what software licenses are required for which procedure.For that reason, the customer did an "off label use" because he presumably did not know the function of the software license in detail.Correction to the severity of this report: the evaluation of reportability has changed to not reportable.Changes can be seen in section b1 and h1.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• 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: 18857845
• Report Number: 9610617-2024-00060
• Device Sequence Number: 14284118
• Product Code: HIG
• UDI-Device Identifier: 04048551376041
• UDI-Public: 4048551376041
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180735
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/07/2024

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
• Device Lot Number: NO04657
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 03/19/2024; 05/21/2024; 08/01/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/10/2024; 05/29/2024; 08/07/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown