MAUDE Adverse Event Report: CONMED CORPORATION CRYSTALVIEW PRO IRRIGATION CONSOLE; ARTHROSCOPE

Catalog Number CV4000

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the cv4000 device was being used during an anterior cruciate ligament reconstruction procedure on (b)(6) 2021 when it was reported that "ran fluid into the patient- could not stitch patient up".After further assessment it was found that "the surgeon had a difficult time closing the leg because of tissue extravasation.The surgeon was able to close the joint he just found this to be significantly more difficult than a typical acl reconstruction.It is assumed that the pump wasn't measuring pressure properly, and because of this, the pump continued pushing fluid into the joint beyond what the set pressure was.The pump pressure was set to either 40-45mm/hg, which would normally not result in such a large degree of tissue extravasation." there was a 10 minute delay to the procedure and the procedure was completed.There was no report of patient impact or injury.The sales representative followed up with the surgeon both immediately post-op, and about 7 days post-op, and at both times the patient was reported to be doing well.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event is unconfirmed.The pump wasn't measuring the pressure properly was not confirmed based on device evaluation.Customer complaint of extravasation has not been confirmed.Talked to sales representative and believe issue was attributed to the nurse placing the blue protective cap for the day use tubeset between the blue inflow tube and the pump.This forces the tubeset away from the sensors and can cause very low pump face pressure readings causing excessive pressure in the joint; although, it could be a sensor issue.We also noticed there was heavy wear on the inflow and outflow rotors which could contribute to excessive noise.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed and no data was found.(b)(4).Per the instructions for use, the user is advised the following: it is the surgeon's responsibility to be familiar with the appropriate surgical technigques prior to use of the equipment and its associated accessories.The volume of distention fluid instilled and drained should be monitored during the procedure.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: CRYSTALVIEW PRO IRRIGATION CONSOLE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 11946010
• MDR Text Key: 268248433
• Report Number: 1017294-2021-00291
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K182882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CV4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1