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 03/18/2024

Event Type  malfunction  

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 Description

The sales representative reported on behalf of the customer that the device, as-ifs1, airseal ifs, 110v, was being used during a robotic pyeloplasty procedure on (b)(6)2024 when it was reported, ¿unit has shut down twice during cases at this facility.".The loss of pneumo was not a gradual loss.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.

Manufacturer Narrative

Evaluation of the device could not replicate the reported event, however it has been confirmed based on the error log on the device.The cable was replaced as the failure could have been caused by a loose contact.Preventative maintenance not overdue.Root cause cannot be determined, however, based upon engineering input; a possible cause of this event could be a defective cord / cable.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 prior data was found.A two-year review of complaint history revealed there has been a total of 82 complaints, regarding 82 devices, for this device family and failure mode.During this same time frame 1,235,038 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 0.00007.Per the instructions for use, the user is advised the following: for your own safety and that of your patient, use only original accessories.The functional test must be performed prior to each surgery.Because the functional test is performed during initial start up, the unit must be power cycled (off/on) prior to each surgery.In case the device or any of the accessories fail during surgery, a replacement device and replacement accessories should be kept within close proximity to be able to finish the operation with the replacement components.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 device, as-ifs1, airseal ifs, 110v, was being used during a robotic pyeloplasty procedure on (b)(6) 2024 when it was reported, ¿unit has shut down twice during cases at this facility.".The loss of pneumo was not a gradual loss.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.

• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 19010453
• MDR Text Key: 339005919
• Report Number: 1320894-2024-00090
• 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: 05/28/2024

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: 03/22/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 05/20/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic