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

Catalog Number	AS-IFS1
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device as-ifs1, airseal ifs, 120v was being used and ¿the airseal unit shut down.¿ per further assessment it was reported that "the power suddenly went out after the pneumoperitoneum had been established, about 20 minutes before the end of the operation.It seems that the pneumoperitoneum was lost all at once." there was no impact or injury to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.The service history was reviewed, and no data was found.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) 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: when working in the airseal mode, it is possible that fluids can be extracted from the surgical field over the evacuation line and into the filter housing.In order to prevent contamination of the device, bodily fluid is retained by the fluid trap of the housing component.The capacity of the fluid trap is limited.A warning message and an audible signal will be emitted if the fill level low is reached.Airseal cannula and tubing placement should be checked to make sure no more fluid enters the fluid trap.At this point, insert airseal obturator and change the filtered tube set.Insufflation can be continued with full functionality.If fluid level high is reached, the airseal function will shut down.Insert obturator in airseal cannula to maintain pressure with normal insufflation.Change the tube set to finish the procedure.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device as-ifs1, airseal ifs, 120v was being used and ¿the airseal unit shut down.¿ per further assessment it was reported that "the power suddenly went out after the pneumoperitoneum had been established, about 20 minutes before the end of the operation.It seems that the pneumoperitoneum was lost all at once." there was no impact or injury to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: AIRSEAL
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8, 4th floor; berlin 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8, 4th floor; berlin 10587 ; GM 10587
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 23450560
• Report Number: 1320894-2025-00251
• Device Sequence Number: 18161199
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)191113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic