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

Catalog Number AS-IFS1

Device Problem Loss of Power (1475)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the as-ifs1, airseal ifs, 110v was being used on (b)(6) 2024 and there was a ¿loss of gas during surgery¿.Per further assessment it was found that "we were in the middle of the procedure and the airseal made a funny noise, and we lost all pneumo.Got the system back up and running and it did the same thing 10-15 mins later.".It was a robotic case and "there was not time to remove the instruments and no patient injury.".This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the as-ifs1, airseal ifs, 110v was being used on (b)(6) 2024 and there was a ¿loss of gas during surgery¿.Per further assessment it was found that "we were in the middle of the procedure and the airseal made a funny noise, and we lost all pneumo.Got the system back up and running and it did the same thing 10-15 mins later.".It was a robotic case and "there was not time to remove the instruments and no patient injury.".This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event of the device losing pnuemo while making a funny noise is confirmed.The unit showed a 90-42 error and the low gas with a full bottle.Recalibrated the unit, performed the safety test, and placed the unit into 12-hour burn-in.The unit was tested.The unit functions as per the specifications.The root cause cannot be determined; however, based upon the evaluation, it could have been a low gas pressure/calibration failure.The service history was reviewed and no relationship to this complaint was found.A device history record (dhr) 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 54 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: 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18789098
• MDR Text Key: 336342454
• Report Number: 1320894-2024-00045
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic