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

Catalog Number AS-IFS1

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.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

The customer reported that the device, as-ifs1, airseal ifs, 110v, was being used during a robot assisted gastrectomy on (b)(6) 2022 when it was reported ¿pneumothorax was confirmed after robot assisted gastrectomy.A few days later the patient was in remission.¿ the report indicated that this was discovered during post-op.The procedure was completed with any delay.There was no report of device malfunction during this event.Further assessment questioning found that there was no report of medical intervention or hospitalization.The current status of the patient is listed as ¿remission after a few days¿.This report is being raised on the basis of injury due to the report of patient with pneumothorax.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.A dhr review was not conducted as the device has been in the field more than 12 months.The service history of the device was reviewed, and no data was found for previous service history.A two-year review of complaint history revealed there has been a total of (b)(6) complaints, regarding (b)(6)devices, for this device family and failure mode.During this same time frame (b)(6) 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 (b)(6).Per the instructions for use, the user is advised that 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.

Event Description

The customer reported that the device, as-ifs1, airseal ifs, 110v, was being used during a robot assisted gastrectomy on (b)(6) 2022 when it was reported ¿pneumothorax was confirmed after robot assisted gastrectomy.A few days later the patient was in remission.¿.The report indicated that this was discovered during post-op.The procedure was completed without any delay.There was no report of device malfunction during this event.Further assessment questioning found that there was no report of medical intervention or hospitalization.The current status of the patient is listed as ¿remission after a few days¿.This report is being raised on the basis of injury due to the report of patient with pneumothorax.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 13899881
• MDR Text Key: 287890232
• Report Number: 1320894-2022-00068
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic