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

Catalog Number AS-IFS1

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2022

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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

In an article published online on (b)(6) 2022, titled, impact of airseal insufflation system on respiratory and circulatory dynamics during laparoscopic abdominal surgery, regarding the as-ifs1, airseal ifs, 110v, which pertained to laparoscopic hepatectomy, gastrectomy, colectomy, or proctectomy procedures performed during the time frame of january 2020 and december 2020 has reported, ¿of the 333 patients, nine (2.7%) showed significant positive responses¿.Which can indicate possible co2 embolism.¿.It is unknown if any or all of these cases have been reported to conmed previously.The article does not indicate a malfunction of the device nor state any medical intervention or hospitalization for any patient.The article also does not indicate that any of the nine patients were actually diagnosed with embolism.This report is being raised on the basis of injury due to the article reporting possible co2 embolism.

Event Description

In an article published online on 29sep2022, titled, impact of airseal insufflation system on respiratory and circulatory dynamics during laparoscopic abdominal surgery, regarding the as-ifs1, airseal ifs, 110v, which pertained to laparoscopic hepatectomy, gastrectomy, colectomy, or proctectomy procedures performed during the time frame of january 2020 and december 2020 has reported, ¿of the 333 patients, nine (2.7%) showed significant positive responses which can indicate possible co2 embolism.¿ it is unknown if any or all of these cases have been reported to conmed previously.The article does not indicate a malfunction of the device nor state any medical intervention or hospitalization for any patient.The article also does not indicate that any of the nine patients were actually diagnosed with embolism.This report is being raised on the basis of injury due to the article reporting possible co2 embolism.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have not been reviewed because the serial number was not known.The service history record was not reviewed because the serial number was not known.A two-year review of complaint history revealed there has been a total of 16 complaints, regarding 16 devices, for this device family and failure mode.During this same time frame (b)(4) 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)(4).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.We will continue to monitor for trends 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; 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: 16712013
• MDR Text Key: 313008664
• Report Number: 1320894-2023-00067
• 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,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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-IFS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 05/26/2023
• 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 Ethnicity: Non Hispanic