MAUDE Adverse Event Report: CONMED LARGO CRYSTALVIEW; ARTHROSCOPE

Catalog Number	CV4000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional 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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text: device not yet received.
Event or Problem Description
A sales representative reported on behalf of a customer that the cv4000, crystalview pro irrigation console was used on (b)(6) 2024 and ¿they experienced a patient getting into cardiac arrest during arthroscopic shoulder surgery.They wanted us to control/calibrate the pumps pressure settings to clear that the pump didn´t cause any damage.I went to the clinic and talked to the surgeon & anesthesiologist at 12.30 cet: the procedure was done on the patient¿s left side with the patient placed on his stomach.Cv4000 was set to a pressure of 50 mmhg.After approximately 40 minutes they were wrapping up the surgery and that¿s when the patient went into cardiac arrest.They preformed cpr and the patient was later transported to hospital.The patient had no known kidney or heart disease and had never undergone any shoulder- or lung surgery.¿.Further assessment found there was no known device malfunction, and the user did not indicate that the cv4000 device caused the patient¿s cardiac arrest, but "wants to eliminate all possible factors for the incident and wishes to have the pump settings controlled so they know that the set pressure was what it was set to be.The patient was discharged from the hospital [on (b)(6) 2024].Head nurse reported that the patient is ok.".This report is being raised due to the reported injury of cardiac arrest, with no report of a device malfunction.
Additional Manufacturer Narrative
Evaluation of the device had its error log downloaded and reviewed for any error events.No anomalies found for the time period of operation concerning this event.Evaluated, repaired, calibrated and tested.Sro evaluation found motor shaft loose and replaced the shuttle valve motor assembly.Repair/evaluation completed.Final test completed and met all specifications.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 prior data was found.A two-year review of complaint history revealed there has been a total of one report, regarding one device, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised to carefully read the conmed tube sets instruction manuals for detailed instructions regarding the proper use and set-up of the irrigation system console, irrigation system tubing and irrigation system accessories before using the conmed crystalview¿ pro irrigation console.Do not allow this device to run unattended.Patient safety requires that the equipment be continuously monitored during operation under the supervision of a trained and licensed physician.Console must be placed at the same height as the patient for accurate pressure settings.Do not place any adhesive labels on the front of the console.Pressure sensor readings can be blocked.Pressure readings can be displayed in mmhg or in levels of h2o, leading to possible erroneous interpretation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the cv4000, crystalview pro irrigation console was used on (b)(6) 2024 and ¿they experienced a patient getting into cardiac arrest during arthroscopic shoulder surgery.They wanted us to control/calibrate the pumps pressure settings to clear that the pump didn´t cause any damage.I went to the clinic and talked to the surgeon & anesthesiologist at 12.30 cet: the procedure was done on the patient¿s left side with the patient placed on his stomach.Cv4000 was set to a pressure of 50 mmhg.After approximately 40 minutes they were wrapping up the surgery and that¿s when the patient went into cardiac arrest.They preformed cpr and the patient was later transported to ¿ hospital.The patient had no known kidney- or heart disease and had never undergone any shoulder- or lung surgery.¿.Further assessment found there was no known device malfunction, and the user did not indicate that the cv4000 device caused the patient¿s cardiac arrest, but "wants to eliminate all possible factors for the incident and wishes to have the pump settings controlled so they know that the set pressure was what it was set to be.The patient was discharged from the hospital [on (b)(6) 2024].Head nurse reported that the patient is okay.".This report is being raised due to the reported injury of cardiac arrest, with no report of a device malfunction.

• Brand Name: CRYSTALVIEW
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20758982
• Report Number: 1017294-2024-00138
• Device Sequence Number: 9263703
• Product Code: HRX
• UDI-Device Identifier: 30653405987509
• UDI-Public: (01)30653405987509(11)240412
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K182882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: CV4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic