MAUDE Adverse Event Report: W.O.M WORLD OF MEDICINE GMBH AIRSEAL IFS, 110V; INSUFFLATION UNIT

Catalog Number AS-IFS1

Device Problem Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

The report 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

Conmed (b)(4) reported on behalf of their customer that the as-ifs1, displayed error message during surgery on (b)(6) 2019.The exact error message is not known.The error caused the device to stop insufflation.Suddenly, there was a loss of pneumoperitoneum that caused the surgeon to advise, in his opinion, that this was a dangerous, critical situation for his patient.Due to the surgeon's opinion and this occurring during a robotic assisted, laparoscopic prostatectomy, conmed (b)(4) has deemed this incident to be reportable to the pdma in (b)(6).Due to that filing to the pdma, conmed usa will be filing to the us fda.The procedure was completed as planned with another air seal unit.There was no reported patient injury or impact.After this incident (procedure), the reported air seal unit was used in other surgeries the same day with no issues.This report is being raised due to device malfunction.

Manufacturer Narrative

Additional information upon further investigation of the incident it was discovered that a surgical staff member had accidently bumped into the lever that locks the tubing into place.When to tubing was knocked loose the insufflation was lost.Evaluation: assessment of the device by the customer found nothing wrong with the unit however it was found that the tubing filter locking lever could easily be moved upward allowing the tubing filter to disengage from the device.The cause of this issue, per the customer, is that one of the surgical staff accidentally contacted the locking lever which allowed the tubing assembly to disengage from the device.Evaluation of the returned device found that when airseal units are returned for repair/ servicing, the locking lever closure force is typically higher than after servicing due to the lever being cleaned and lubricated.Additionally, a review of 4 units for locking lever closure force prior to and after servicing show that that force is lower after servicing.The service history was reviewed, and no data was found.As the device is in excess of 5 years of age, the dhr was not reviewed.A two-year review of complaint history revealed there has been 38 complaints regarding 38 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.012 per the instructions for use, the user is advised the following; - in case the device or any accessories fail during surgery, a replacement device and accessories should be kept within close proximity in order to finish the operation.- conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: INSUFFLATION UNIT
• Manufacturer (Section D): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin, 10587 ; GM 10587
• MDR Report Key: 9459962
• MDR Text Key: 206850296
• Report Number: 3006217371-2019-00419
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K172516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1