MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ARTHROPUMP POWER SUCTION/IRRIGATION PUMP

Model Number	28340720-1
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product not yet returned; no evaluation results available.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): the pump independently increases pressure.The ankle joint stretched too much.

• Brand Name: ARTHROPUMP POWER SUCTION/IRRIGATION PUMP
• Common Device Name: SUCTION/IRRIGATION PUMP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 10788090
• Report Number: 9610617-2020-00116
• Device Sequence Number: 18992897
• Product Code: HRX
• UDI-Device Identifier: 04048551112144
• UDI-Public: 4048551112144
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 28340720-1
• Device Catalogue Number: 28340720-1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/04/2020
• 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