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

Model Number	031524-10
Medical Device Problem Codes	Leak/Splash (1354); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
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 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
As the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.The investigation was completed on 2024-05-28.The device product history records (dhr) have been checked for the available lot number and found to be according to the specification, valid at the time of production.Based on the available information, the failure description and similar complaints, most likely the root cause is assembling error, mechanical damaged membranes during setup or leaking tubing joint near the membranes.There is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can most likely be traced back to a usage-related failure internal karl storz reference number: (b)(4).
Additional Manufacturer Narrative
Correction is made in dection b1 and h1 to change the severity of the event from an adverse event to a malfunction.No harm to patient, user or is third reported.The event is filed under internal karl storz complaint id: (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
• 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: 18960720
• Report Number: 9610617-2024-00078
• Device Sequence Number: 7348979
• Product Code: OCX
• UDI-Device Identifier: 04048438006337
• UDI-Public: 4048438006337
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 01/27/2025

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: 32335143
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 05/28/2024; 01/23/2025
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 06/03/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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