MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY INSUF(ENGL ,GERM,FRENCH,SPANISH); INSUFFLATOR, LAPAROSCOPIC

Model Number SYNERGY INSUF(ENGL ,GERM,FRENCH,SPANISH)

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

Patient Problems Arrhythmia (1721); Cyanosis (1798); Low Oxygen Saturation (2477); No Code Available (3191)

Event Date 08/20/2020

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.

Event Description

It was reported that a patient underwent a laparoscopic assisted vaginal hysterectomy on (b)(6) 2020.During this procedure, the anaesthetist noted that co2 pressures had dropped significantly and the patient's o2 saturations had also dropped.Cardiac arrhythmia was then noted on ecg; possible vf.Emergency/met call was initiated and the patient's head was moved down in lithotomy position.The drapes were pulled back and the patient cyanosed.Patient asystole.The operating table was leveled out and cpr commenced.Cpr performed for 10 seconds before patient reverted back to sinus rhythm.Anaesthetic gases were turned off; 100% o2 and intravenous anaesthetic solely used.Anaesthetist informed hospital intensivist, to review patient in recovery.Surgery was ok to continue as patient was now stable.Intensivist reviewed, to go to hdu post op and cardiac review/investigation.At time of event, the surgeon had performed the laparoscopic part of the procedure and was removing the uterus vaginally.No co2 gases (laparoscopic insufflation) were on at the time.The pressure was set at 15 abd the flow was- high flow ¿ set at 20.Gas was turned off at time of incident.

Manufacturer Narrative

The reported incident could not be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.Functional inspection based on most recent test instruction release indicated the returned device passed all criteria.This included a pressure test, flow test, occlusion and overpressure alarms test with a result of each passed.This submission contains additional information that was obtained and has been entered in section b5.

Event Description

It was reported that a patient underwent a laparoscopic assisted vaginal hysterectomy on (b)(6) 2020.During this procedure, the anaesthetist noted that co2 pressures had dropped significantly and the patient's o2 saturations had also dropped.Cardiac arrhythmia was then noted on ecg; possible vf.Emergency/met call was initiated and the patient's head was moved down in lithotomy position.The drapes were pulled back and the patient cyanosed.Patient asystole.The operating table was leveled out and cpr commenced.Cpr performed for 10 seconds before patient reverted back to sinus rhythm.Anaesthetic gases were turned off; 100% o2 and intravenous anaesthetic solely used.Anaesthetist informed hospital intensivist, to review patient in recovery.Surgery was ok to continue as patient was now stable.Intensivist reviewed, to go to hdu post op and cardiac review/investigation.At time of event, the surgeon had performed the laparoscopic part of the procedure and was removing the uterus vaginally.No co2 gases (laparoscopic insufflation) were on at the time.The pressure was set at 15 abd the flow was- high flow ¿ set at 20.Gas was turned off at time of incident.Additional information provided 9/4/2020: the delay in the case lasted 30 min.The patient was discharged from the hospital on (b)(6) 2020.

• Brand Name: SYNERGY INSUF(ENGL ,GERM,FRENCH,SPANISH)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10484032
• MDR Text Key: 205471701
• Report Number: 1220246-2020-02136
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 00888867100817
• UDI-Public: 00888867100817
• Combination Product (y/n): N
• PMA/PMN Number: K030837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYNERGY INSUF(ENGL ,GERM,FRENCH,SPANISH)
• Device Catalogue Number: AR-3290-0001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other