MAUDE Adverse Event Report: ARTHREX, INC. DW OUTFLOW CASSETTE/TUBE SET; ARTHROSCOPE

Model Number DW OUTFLOW CASSETTE/TUBE SET

Device Problem Inaccurate Delivery (2339)

Patient Problem Swelling/ Edema (4577)

Event Date 10/04/2021

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.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a shoulder arthroscopy the shoulder swelled a lot.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.25-oct-2021 update dw: further information were provided that an ar-6420 and ar-6430 tube was used during the procedure and was then discarded.The pump was set for a shoulder arthroscopy (pressure 50mmhg) and no alarm/error messages occurred during use.The pump delivered more fluid then expected and could be resolved by lowering the pressure (40/45mmhg).It was further reported that no clamp test was performed and the additional liquid was removed immediately with the use of a cannula.

• Brand Name: DW OUTFLOW CASSETTE/TUBE SET
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12697640
• MDR Text Key: 278560264
• Report Number: 1220246-2021-03856
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039322
• UDI-Public: 00888867039322
• 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
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DW OUTFLOW CASSETTE/TUBE SET
• Device Catalogue Number: AR-6430
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other