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

Catalog Number AS-IFS2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infiltration into Tissue (1931)

Event Date 12/10/2021

Event Type  Injury  

Manufacturer Narrative

Reported event is inconclusive.The device is not being returned and no photographic evidence was provided.Therefore, the reported failure could not be verified the service history was reviewed, and no data was found.A review of the device history review has been requested from the supplier, but to date it has not been received.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 7 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 0.004.Per the instructions for use, the user is advised the following: use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.Ensure that adequate pneumoperitoneum or pneumorectum is established; ensure that the patient is properly positioned so that organs are away from the penetration site; direct the airseal access port¿s tip away from significant vessels and organs; do not use excessive downward force and once a safe and proper entry has been achieved, ensure that the black line at the distal tip of the airseal access port is visible within the cavity at all times the airseal access port is being used for insufflation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the device, as-ifs2, airseal ifs, 230v was being used on 10dec21 during a laparoscopic rectopexy for rectal prolapse procedure and ¿the patient presented with extensive surgical emphysema (including chest, neck, face, arms).It was only discovered once all the drapes came off her, and she was in lithotomy for around 3 hrs.Anesthetist had noticed increased expiratory co2 during case and had been increasing her ventilation.The surgeon reported causes to be multi-factorial, in that she was 82 with bmi 16 and very poor tissues.He had used one 12mm airseal and three 5mm (ethicon) ports, in airseal mode at +12mmhg.Interestingly, her tissues were so poor that when he removed the 5mm ports, she still had holes that he could see through, so he closed each 5mm port site with trans-fascial sutures - something he would never ordinarily need to do.This was before they had discovered the surgical emphysema.She was so swollen when she awoke that we initially planned to transfer her to icu at southwest healthcare from st john of god, but they had no beds, so dr (director of anesthetics) kept her ventilated in theatre for another 3+ hours until her swelling reduced enough that he was happy to eventually extubate her.The patient had no issues following her extubation yesterday and is going home today ((b)(6) 2021) with no discharge medications (no pain).She still has some surgical emphysema but continuing to resolve.¿ the procedure was completed and there was a 30 plus minute delay.This report is being raised on the basis of injury due to subcutaneous emphysema.

• Brand Name: AIRSEAL IFS, 230V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin 10587 ; GM 10587
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13175322
• MDR Text Key: 286244435
• Report Number: 1320894-2022-00007
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• 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
• Treatment: 12MM AIRSEAL PORT; THREE 5MM (ETHICON) PORTS,
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic