MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBING SET, IRRIGATION, FC

Model Number	031524-10
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two used cassette hose sets from two different batches were leaking at the pressure diaphragm after insertion into the endomat select up210 pump.The rinsing fluid escaped via the defective membrane after the pump was started up and flooded the equipment trailer with the equipment underneath.No harm to patient, user or third reported.
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).

• Brand Name: TUBING SET, IRRIGATION, FC
• Common Device Name: TUBING SET
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18952059
• Report Number: 2020550-2024-00076
• Device Sequence Number: 7050583
• Product Code: OCX
• UDI-Device Identifier: 04048438006337
• UDI-Public: 4048438006337
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/21/2024
• Report Date (Section F): 03/21/2024

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: 031524-10
• Device Catalogue Number: 031524-10
• Device Lot Number: 32284433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2024
• 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