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

Catalog Number AS-IFS1

Device Problem Inflation Problem (1310)

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Secondary fda product code is gcj.(b)(4).The reported 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

The customer reported that the device, as-ifs1, caused subcutaneous emphysema to a patient on an unknown date and during an unknown procedure.Further assessment questioning was requested; however, the surgeon will not respond.This report is being raised on the basis of injury due subcutaneous emphysema.

Manufacturer Narrative

An evaluation of the returned device found no fault.The compressor age is 1 year, 9 months.((b)(6) 2019).Performed the annual inspection with no problems.Calibrated unit, performed safety test, and placed the unit into 12 burn-in.The unit completed and passed the 12-hour burn-in test.The unit was tested per ip-800-031.The unit functions as per the specification.A review of the dhr by the contract manufacturer indicated that 6 devices were manufactured with the work order and accepted into final stock in (b)(6) 2015 with no reported discrepancies.The service history was reviewed and no relationship to this complaint was found.A two-year review of complaint history revealed there has been a total of 9 complaints, regarding 9 devices, for this device family and failure mode.During this same time frame 1,959 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.005.Per the instructions for use, the user is advised the following: precautions: higher insufflation pressures (> 15 mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, sucutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum, and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin 10587 ; GM 10587
• MDR Report Key: 10704450
• MDR Text Key: 212102478
• Report Number: 3006217371-2020-00457
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other