MAUDE Adverse Event Report: W O M WORLD OF MEDICINE GMBH AIRSEAL IFS, 230V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS2
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Additional 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.H3 other text : device not yet received.
Event or Problem Description
The distributor reported on behalf of their customer that the device, as-ifs2, airseal ifs, 230v, was being used during a robotic hysterectomy procedure on (b)(6) 2024 when it was reported, ¿airseal system shut down without pre warning during robotic gyn procedure.The customer was not able to restart this system.They had to take in a generic insufflator to finish the case.There was no injury to the patient.The next day the system worked normally during the cases.¿.Further assessment questioning found that there was a rapid loss of pneumo.The instrumentation was removed safely from the patient.The procedure was completed using a generic insufflator causing a 15-20-minute delay in the procedure.The patient was reported as ¿doing fine¿.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The distributor reported on behalf of their customer that the device, as-ifs2, airseal ifs, 230v, was being used during a robotic hysterectomy procedure on (b)(6) 2024 when it was reported, ¿airseal system shut down without pre warning during robotic gyn procedure.The customer was not able to restart this system.They had to take in a generic insufflator to finish the case.There was no injury to the patient.The next day the system worked normally during the cases.¿.Further assessment questioning found that there was a rapid loss of pneumo.The instrumentation was removed safely from the patient.The procedure was completed using a generic insufflator causing a 15-20-minute delay in the procedure.The patient was reported as ¿doing fine¿.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device was not overdue for preventative maintenance.The device did receive a software update and the complaint could not be duplicated during a 12-hour test.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed and no relationship to this complaint was found.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(6) 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 failure to properly follow the instructions for use can lead to serious surgical consequences.Only qualified physicians with knowledge, experience, and training in laparoscopic techniques should use the components of the airseal system.These instructions for use do not include descriptions or instructions for surgical techniques or laparoscopic procedures.It is the responsibility of the physician performing any procedure to determine the appropriateness of the type of procedure to be performed with the use of these products and to determine the specific technique for each patient.Make sure the connection data and technical specifications of the power supply comply with dinvde or national requirements.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: AIRSEAL IFS, 230V
• Common Device Name: 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; 5salzufer 8; berlin 10587 ; GM 10587
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 19485160
• Report Number: 1320894-2024-00146
• Device Sequence Number: 7924068
• Product Code: HIF
• UDI-Device Identifier: 10851885004594
• UDI-Public: 10851885004594
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: AS-IFS2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS INSUFFLATOR; OLYMPUS INSUFFLATOR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic