MAUDE Adverse Event Report: ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problems Alarm Not Visible (1022); Increase in Pressure (1491); Suction Problem (2170); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during surgery/ treatment the pump delivers too much pressure and pumps too much water into the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a the same device used anyway.It was not necessary to switch the surgical technique or do a second surgery.No further information received.***update, 01-feb-2021 -sac: received further information that the pump does not work properly with the shaver, that means the pressure is too high, the rinse and suction does not work properly.But there is no alarm/ error message.There has no clamp test been performed.Furthermore, the used tubes cannot be determined anymore, have been discarded by facility.There was no harm for patient, operator or third party reported.

Manufacturer Narrative

The complaint was not confirmed.The returned pump was visually inspected and showed no physical damage on the unit.Further review of the pump sub-assembly and components showed no issues with the latch door or tubing connector.Tub sets or shaver console was not returned for evaluation.The pump was assembled with a new ar-6410 arthroscopy pump tubing, a new ar-6430 dw outflow cassette and a known good ar-8305 shaver console.To be tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The pump was powered on and function as intended with no error message and/or audible alarm triggered.Among the most common causes for this type of issue/occurrence are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump or (2) spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11275642
• MDR Text Key: 231373131
• Report Number: 1220246-2021-02542
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Device Catalogue Number: AR-6480
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other