MAUDE Adverse Event Report: CONMED LINVATEC ARTHROSCOPY PUMP CASSETTE LOAD; ARTHROSCOPE

Catalog Number 87000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Weakness (2145); Complaint, Ill-Defined (2331); Inadequate Pain Relief (2388); Pallor (2468); Patient Problem/Medical Problem (2688)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

Although the 87000 arthroscopy pump is expected for evaluation, the product has not yet been returned.When the device is returned, conmed will perform an evaluation and upon completion will file a supplemental medwatch report.

Event Description

The user facility reported the patient was scheduled for a left knee arthroscopy on (b)(6) 2016 and had a left medial meniscectomy completed.The surgeon complained about not being able to see the surgical field as clearly as normal, but the pump did not seem to act out of the ordinary.A tourniquet was applied to the left leg and was set at 325 mg with a 45-minute tourniquet time.Once the case was completed, the patient was watched closely as she was complaining about pain and had a little more swelling than normal.The patient's toes were pale in color immediately following the procedure and her pedal pulses were faint.After several hours in recovery, the patient was discharged home and instructed to follow up with the surgeon on (b)(6) 2016 per normal follow-up procedure.On (b)(6) 2016, follow up visit with the surgeon the patient was complaining about pain and must have shown abnormal signs of healing following an arthroscopic procedure, as the surgeon sent her to a hospital for further evaluation.On (b)(6) 2016 - once the patient arrived at the hospital she had another surgery due to swelling and the surgeon chose to leave the site open with plans to return to close the wound on (b)(6) 2016.On (b)(6) 2016- patient returned to the operating room to have wound closed but the surgeon would not close it due to the poor condition of the wound.An amputation was recommended to the patient.At that time, the patient refused an amputation and remained in hospital.On (b)(6) 2016- patient agreed to have amputation.A below knee amputation was scheduled.Once the surgeon got into the case an above the knee amputation was conducted.The pump was used again in a following case with no functional issues noted.Pumps and other equipment usually serviced by a third party.This pump was last serviced by conmed 01/27/2012.

Manufacturer Narrative

The arthroscopy pump was received along with the tubing set for evaluation.The pump and tubing set were tested by r&d engineering.Electrical safety tests, power up, switch operations, lighted displays, motor stop and message lights, multi step up/down, flow, pressure sensing accuracy and valve operations were all checked.This pump was found to work as designed and all safety features were fully functional.The evaluation found no functional or performance issues and therefore could not verify any association with the use of this device to the reported patient injury event.A two-year review of complaint history for this device shows there has been no other adverse event reported that was associated with the use of the arthroscopy pump cassette load.Since there were no defects reported and the device functioned without error, a failure mode cannot be identified for a risk analysis.A review of service and repair history shows the last time this device was repaired/serviced was on 01/27/2012.Preventive maintenance is overdue.According to the instructions for use, the user is advised that linvatec service inspection is required annually.

• Brand Name: ARTHROSCOPY PUMP CASSETTE LOAD
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept boulevard; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept boulevard; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept boulevard; largo, FL 33773 ; 7273995515
• MDR Report Key: 6190533
• MDR Text Key: 62916193
• Report Number: 1017294-2016-00137
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 87000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 62 YR