MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SINGLE USE TUBING SET FOR ARTHROPUMP; ARTHROPUMP TUBING

Model Number	031328-10
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has not yet been returned for investigation.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(4): after mounting the tubing on the arthropump, leakage of physiological serum observed.Consequent leakage after insertion of the arthroscope into the joint concerned (pump blockage); stopped the operation and used a different tubing.
Additional Manufacturer Narrative
The tubing set was returned for investigation on november 09, 2020.Upon evaluation, it could be confirmed that there is leak at the connection area.The concrete root cause could not be identified, however the leakage at the connection area is potentially due to gluing or mechanical damage such as bend this is the first case in total (b)(4) product sold worldwide.

• Brand Name: SINGLE USE TUBING SET FOR ARTHROPUMP
• Common Device Name: ARTHROPUMP TUBING
• 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: 10792541
• Report Number: 9610617-2020-00118
• Device Sequence Number: 16761784
• Product Code: HRX
• UDI-Device Identifier: 04048438002964
• UDI-Public: 4048438002964
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K990911
• 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,Followup
• Report Date (Section B): 08/08/2022

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 Expiration Date: 09/17/2024
• Device Model Number: 031328-10
• Device Catalogue Number: 031328-10
• Device Lot Number: W-029986
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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