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

Catalog Number AS-IFS1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a legal notice received on 19dec22.The device as-ifs1, airseal ifs, 110v was reported as having been used during a procedure where ¿airseal ifs made an unfamiliar noise¿ and the surgeon converted the procedure to laparotomy.This was during a robot-assisted laparoscopic supracervical hysterectomy procedure that occurred on 12aug19.This report is being raised on the basis of injury due to converting to laparotomy.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The service history could not be performed since a serial number was not provided.A device history record review cannot be conducted as a serial number was not provided.A two-year review of complaint history revealed there has been a total of 1 report, regarding 1 device, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised the following: press the on/off switch.The device now initializes and then runs the initial self-test.The start screen and a progress bar are depicted on the display during the initial self-test.If the initial self-test was unsuccessful, an error message and information about how to possibly remedy the problem are displayed.An acoustic warning signal is emitted.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a legal notice received on 19dec22.The device as-ifs1, airseal ifs, 110v was reported as having been used during a procedure where ¿airseal ifs made an unfamiliar noise¿ and the surgeon converted the procedure to laparotomy.This was during a robot-assisted laparoscopic supracervical hysterectomy procedure that occurred on (b)(6) 2019.This report is being raised on the basis of injury due to converting to laparotomy.

• 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: 16148344
• MDR Text Key: 307197915
• Report Number: 1320894-2023-00006
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Non Hispanic