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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Event Description

Conmed japan reported on behalf of their customer that the device, as-ifs1, airseal ifs, 110v device was being used on (b)(6) 2024 during an unnamed procedure and ¿the pneumoperitoneum fell while using air seal, and when looking at the screen, it was blacked out.¿.Follow-up assessment determined that this event occurred during a robotic case, and pneumoperitoneum was lost rapidly.There was no injury reported.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no 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.(b)(4).Per the instructions for use, the user is advised to maintain adequate gas supply at all times.Depending on age and health condition of the patient, the lowest possible flow and pressure for establishing the pneumoperitoneum/pneumorectum or for use in the thoracic cavity should be selected.It is not recommended to exceed insufflation pressures of 15 mmhg in colorectal procedures, 10 mmhg in thoracic procedures or 15 mmhg in pediatric procedures.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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18687068
• MDR Text Key: 336510836
• Report Number: 1320894-2024-00028
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic