MAUDE Adverse Event Report: ARTHREX, INC. CWIII ARTHROSCOPY PUMP; ARTHROSCOPE

Model Number CWIII ARTHROSCOPY PUMP

Device Problem Increase in Pressure (1491)

Patient Problems Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 07/21/2021

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 knee arthroscopy surgery fluid was pumped into the joint with too much pressure despite the pump settings.The failure led to a swelling of the knee joint and a soft tissue injury to the patient.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.The surgery time was extended by approx.15-20 min due to the error.Update 23-jul-2021: it was confirmed that the patient suffered no visible soft tissue injuries.An arthrex pump was used with the device and the settings initially showed 45/70, then 30/75 and sometimes switched off.No error messages were noticed.The error resulted in a swelling in the distal thigh and lower leg and knee joint.The patient was treated with compression therapy.A clamp test was performed beforehand.Update 23-sep-2021: the pump ar-6475 / sn: (b)(4) used with the reported device was added in the case.

• Brand Name: CWIII ARTHROSCOPY PUMP
• 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: 12615585
• MDR Text Key: 278528556
• Report Number: 1220246-2021-03779
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039346
• UDI-Public: 00888867039346
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K024291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CWIII ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other