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

Model Number 031328-10

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

Product has not yet been returned for investigation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 216937429
• Report Number: 9610617-2020-00118
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04048438002964
• UDI-Public: 4048438002964
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K990911
• 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,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 031328-10
• Device Catalogue Number: 031328-10
• Device Lot Number: W-029986
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other