MAUDE Adverse Event Report: ARTHREX, INC. MAIN PUMP TUBING; ARTHROSCOPE

Model Number MAIN PUMP TUBING

Device Problems Inability to Irrigate (1337); Structural Problem (2506); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Device disposition is unknown.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It wa reported via fda medwatch letter (mw5087791) that the following incident has been reported: the sensor in fluid chamber of the arthroscopy pump tubing noted to be "flat" in appearance.Did not regulate the inflow of irrigation fluid to left knee, causing fluid subligation to subcutaneous tissue left knee to groin.Procedure: arthroscopy left knee.The medwatch letter did not contain any reporter or facility name or contact information.Therefore no follow up can be performed at this time.

• Brand Name: MAIN PUMP TUBING
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 8861639
• MDR Text Key: 153364972
• Report Number: 1220246-2019-01229
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867118010
• UDI-Public: 00888867118010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: MAIN PUMP TUBING
• Device Catalogue Number: AR-6410
• Device Lot Number: 32454024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other