MAUDE Adverse Event Report: ALSA APPARATUS, EXHAUST, SURGICAL

Model Number CS-900/LC

Device Problem Premature Activation (1484)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

During a laparoscopic liver surgery, an aqm was used with a smoke evacuator (alsa cs-900/lc), which was supposed to be activated only when monopolar bovie was used.All connections were appropriate; the 2 generators (aex and conmed bovie) were far apart and connected to 2 different power sockets and the patient return electrode was on the left thigh.Every time the aqm was activated, the smoke evacuator also got activated; although the monopolar electrocautery was not in use.The monopolar electrosurgery sensor was connected to the return electrode.Customer suspects that energy traveled from the aquamantys to the return electrode.There were no patient symptoms or complications associated with this event.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: APPARATUS, EXHAUST, SURGICAL
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): ALSA
• MDR Report Key: 17530787
• MDR Text Key: 321385494
• Report Number: MW5137705
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: CS-900/LC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1