MAUDE Adverse Event Report: W.O.M WORLD OF MEDICINE GMBH AISEAL IFS 230V; INSUFFLATION UNIT

Catalog Number AS-IFS2

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

The product is not expected to be returned, however, the complaint investigation is ongoing.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Conmed (b)(6) was made aware of a complaint on 3/18/20 regarding the as-ifs2, airseal insufflation unit.The airseal was used in a single anastomosis duodeno-ileal bypass on (b)(6) 2020.During post-op follow up the surgeon was made aware that the patient was diagnosed with a pneumomediastinum post operatively and the surgeon inquired as to possible cause as he had been using the airseal.The patient was doing fine currently.The conmed representative inquired about the post op events and was told the patient went to icu as planned post op and it was there that blood gas levels were taken, and troponin was noted to be 300 resulting in a call to the cardiologist.Chest x-ray revealed air in the mediastinum and ct showed air around the heart.The surgeon commented he didn't do a hiatal hernia repair, which if he had done, he would've accepted that is where air got into the chest but commented there can be small congenital holes present.He noted he used the tisseal sealer, which has a co2 applicator and he wondered if that increased pressure had caused the air to migrate.The surgeon stated the airseal pressure was 12mmhg and the operation was 2 hours in length and completed routinely.The patient was discharged on (b)(6) 2020, which surgeon stated is the usual length of stay.The patient made a full recovery with no adverse effects.This report is being raised due to device malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence has been provided.The service history was reviewed, and no prior data was found.A dhr review was requested from manufacturer w.O.M world of medicine gmbh, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been 1 complaint regarding 1 devices for this device family and failure mode.During the same time frame 2,078 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.0005 per the instructions for use, the user is advised the following; - higher insufflation pressures (>15 mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AISEAL IFS 230V
• 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: 9963715
• MDR Text Key: 219156506
• Report Number: 3006217371-2020-00149
• 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: 04/29/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1