MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AIRSEAL IFS, 230V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number AS-IFS2

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

Patient Problem Pulmonary Emphysema (1832)

Event Type  Injury  

Manufacturer Narrative

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 distributor reported on behalf of their customer that the as-ifs2 was being used during a robotic surgery when it was reported "some patients had emphysemas after being operated with this unit.Distributor just sending item to be checked, as they think it's just a product misuse." further assessment questions were sent to the user facility; however, they declined to answer anything further.Follow up with the marketing manager found that the distributor has reported that these incidents are cause by user error and the conmed device has not malfunctioned.The facility is scheduled for retraining of the new personnel.This report is being raised on the basis of injury due to report of emphysema.

Manufacturer Narrative

The diagnostics evaluation found the pm was not overdue, and the unit was not misused.Additional problems were found.The response time and calibration failed.The unit was serviced, and the oxygen sensor was replaced.A device history record review was requested from the manufacturer, and a response was not received.The service history was reviewed.(b)(4).Per the instructions for use, the user is advised that higher insufflation pressures (>15mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.Failure to properly follow the instructions for use can lead to serious surgical consequences.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL IFS, 230V
• 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: 11945809
• MDR Text Key: 254525327
• Report Number: 1320894-2021-00286
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other