MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOMAT® SELECT; SURGICAL IRRIGATION / SUCTION SYSTEM

Model Number	UP210
Medical Device Problem Codes	Use of Device Problem (1670); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As a preliminary result, it can be concluded that the customer used a software that was not intended for the described treatment.The manufacturer is waiting for further information regarding the incident.Further investigations will be planned as soon as more details are available.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): it was reported that the customer used an arthroscopy setup endoscope setup for a hysteroscopy.Since the arthroscopy software is not intended for this type of treatment, the customer provoked an embolism.According to customer's information, the patient has recovered completely.
Additional Manufacturer Narrative
According to the investigation results, the wrong license was used (arthroscopy instead of hysteroscopy), where the flush volume and pressures have different limits.The irrigation pressure limit of the hysteroscopy software is 100 mmhg due to safety reasons.For this case, the most probable root cause is that the embolism was caused by a too high pressure.The customer will be informed about the misuse.
Additional Manufacturer Narrative
This supplement report is filed to correct both the date of incident and the date report was received.

• Brand Name: ENDOMAT® SELECT
• Common Device Name: SURGICAL IRRIGATION / SUCTION SYSTEM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 12460147
• Report Number: 9610617-2021-00065
• Device Sequence Number: 4891722
• Product Code: HIG
• UDI-Device Identifier: 04048551376041
• UDI-Public: 4048551376041
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201355
• 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,Followup
• Report Date (Section B): 12/01/2021

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?: No
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 07/26/2021; 08/26/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 11/10/2021; 12/01/2021
• 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: Female