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

Model Number 28340720-1

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Product not yet returned; no evaluation results available.

Event 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
• Type of Device: SUCTION/IRRIGATION PUMP
• 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: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 10788090
• MDR Text Key: 230671661
• Report Number: 9610617-2020-00116
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04048551112144
• UDI-Public: 4048551112144
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28340720-1
• Device Catalogue Number: 28340720-1
• Date Manufacturer Received: 10/09/2020
• Date Device Manufactured: 07/25/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other