MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Model Number	SYNERGY INSUFFLATOR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported the facility has had three patients showing high carbon dioxide levels.They are not certain that the insufflator is causing the problem, but they want to exchange the device.Additional information obtained 9/17/20: the facility reporter states that over a 2 to 3 week period it was discovered across different anesthesiologist that there were 3 cases of higher than normal co2 levels measure on the anesthesia machine.Since the incidents were random, over a few weeks time and with several different doctors it was not discovered right away that there may be an issue.There were no patient injuries or death.Specific case details were not noted and are not available to provide.The anesthesia machine was removed from service for maintenance and calibrations.The insufflator, out of an abundance of caution was also removed from the room and was being sent back to arthrex for exchange.
Additional Manufacturer Narrative
The returned device matched the report, and the incident was not confirmed.Further functional testing based on actual valid test instruction indicated the device passed to meet the criteria detailed.Self-test passed.Several errors have been logged which are not related to the reported event.Flow and pressure tests were performed.All values are within specification.The review of the risk assessment for the failure mode indicated the issue was within tolerance, therefore no corrective actions are deemed necessary at this time.The most possible root cause is the use of too high pressure because high pressure promotes co2 absorption.

• Brand Name: SYNERGY INSUFFLATOR
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10548996
• Report Number: 1220246-2020-02179
• Device Sequence Number: 19717510
• Product Code: HIF
• UDI-Device Identifier: 04056702002824
• UDI-Public: 04056702002824
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K030837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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 Model Number: SYNERGY INSUFFLATOR
• Device Catalogue Number: AR-3290-0004
• Device Lot Number: 10112652
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 11/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other