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 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.The service history was reviewed, and no data was found.A two-year review of complaint history revealed there has been a total of 17 reports, regarding 17 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: always position the patient lower than the device to prevent body fluids from leaking into the insufflation tube.Actual pressure may increase and fluid may penetrate the insufflation tube if the patient is repositioned during surgery.If this occurs, immediately disconnect the insufflation tube.When the patient is repositioned onto his or her side, internal tissue may block the insufflation channel.Always insufflate through the elevated side of the patient.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

Conmed japan reported on behalf of a customer that the as-ifs1, airseal ifs, 110v device was being used during a robot-assisted endoscopic rectal resection procedure on (b)(6) 2024, and ¿when using ars and transitioning to air seal mode according to the procedure, a partial clogging error occurred.Surgeons searched for the root causes, but could not find a solution.The surgeon once tried to return to normal pneumoperitoneum, but there was no change on the screen, so when he touched the touch panel on the main unit, it did not respond.After that, a red alert saying "pressure!" suddenly appeared, then the screen went black and the machine shut down.Although the intra-abdominal pressure decreased as the pneumoperitoneum was forcibly terminated, no organs were penetrated by the instrument.The device then restarted automatically.The partial blockage error continued to appear even after restarting, but the alert disappeared when the air tube was replaced with assist.Based on this event, they thought that the cause of the partial blockage was the da vinci cannula seal, but they was concerned that the airseal had lost power, so it was an error.¿ follow-up assessment determined that ¿pneumoperitoneum was suddenly lost".The procedure was completed and there was no injury to patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: 18810903
• MDR Text Key: 337630786
• Report Number: 1320894-2024-00047
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic