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

Catalog Number AS-IFS1

Device Problem Intermittent Loss of Power (4016)

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

Event Date 04/18/2024

Event Type  malfunction  

Event Description

A sales representative reported on behalf of a customer that the as-ifs1, airseal ifs, 110v device was being used during a hysterectomy procedure on 18apr24, and ¿as-ifs1 - the screen went black during a case/ lost insaflation¿.They ¿powerd back on and contuied with the same unit¿, with a delay of 5 minutes.Follow-up assessment found that the event involved a robotic case and a "sudden loss of insufflation" occurred."they were able to re-establish pneumo and finish procedure without incident".There was no reported injury to the patient and no medical/surgical intervention or extended hospitalization required.This report is being raised on the basis of 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.H3 other text : device not yet received.

Manufacturer Narrative

Reported event of ¿sudden loss of insufflation" was unconfirmed.The evaluation found excessive dust throughout unit, and the display gasket not seated fully.The software was updated to version 2.2.1.0.The gasket seal was replaced, and the unit was cleaned.The unit was calibrated and placed unit into 12 hr.Burn-in.The annual inspection was performed.The unit was tested and it functions per specification.The service history was reviewed and found similar repairs to this complaint.A device history record (dhr) review 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 57 reports, regarding 57 devices, for this device family and failure mode.During this same time frame (b)(4) have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, (b)(4).Per the instructions for use, the user is advised the following: special care is necessary when servicing, maintaining, and storing the device and its accessories to maintain the functionality of the device and its accessories.Use the on/off key to turn the device off.Remove the power cable.Wipe the surface of the device with a soft cloth moistened with an appropriate disinfectant (for example meliseptol® rapid).The concentration of the used disinfectant depends on the information provided by the manufacturer of the disinfectant.Make sure moisture does not enter the device.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

A sales representative reported on behalf of a customer that the as-ifs1, airseal ifs, 110v device was being used during a hysterectomy procedure on (b)(6) 2024, and ¿as-ifs1 - the screen went black during a case/ lost insaflation¿.They ¿powerd back on and contuied with the same unit¿, with a delay of 5 minutes.Follow-up assessment found that the event involved a robotic case and a "sudden loss of insufflation" occurred."they were able to re-establish pneumo and finish procedure without incident".There was no reported injury to the patient and no medical/surgical intervention or extended hospitalization required.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: 19180052
• MDR Text Key: 341791167
• Report Number: 1320894-2024-00108
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)180507
• 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: 05/23/2024

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: 04/18/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic