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

Catalog Number AS-IFS1

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

Patient Problem Air Embolism (1697)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The service history was reviewed, and no data was found.A device history record review was not conducted as the device has been in the field more than 12 months.A two-year review of complaint history revealed there has been a total of 6 reports, regarding 6 devices, for this device family and failure mode.During this same time frame 1,100,646 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 0.000005.Per the instructions for use, the user is advised the following: incorrect placement of a cannula or a trocar into subcutaneous tissue may lead to emphysema.To reduce the risk, use a low gas flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned.Long surgeries (> 200 min.), the use of many access points, duration and size of leaks at these points may also contribute to emphysema.Be sure to close leakages in trocar access points immediately.Higher insufflation pressures (> 15 mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Conmed japan reported on behalf of their customer that the device, as-i fs1, airseal ifs, 110v was being used on (b)(6) 2022 during a robotic-assisted rectal surgery procedure when it was reported ¿during surgery, after 3 hours and 30 minutes have passed since the start of the pneumoperitoneum, the message "check for excessive leakage or aspiration" lights up, and the message does not disappear even if the pneumoperitoneum pressure stabilizes.When pneumoperitoneum was repeated 4 hours after the start of pneumoperitoneum, the air seal mode was not changed after the inner cylinder was pulled out (set pressure 8mmhg).After the operation, when it was confirmed in an unclean condition, it shifted to the air seal mode without any problems.Although the cause could not be identified as an air seal, subcutaneous emphysema occurred to the patient's face, and extubation could not be performed after surgery.The patient was transferred to the icu and remained intubated until the day after surgery, where she was scheduled to be extubated the next day.¿ the procedure was completed, and no alternate devise was used.Further assessment found no medical/surgical intervention or prolonged hospitalization was reported."after removing the specimen through a small incision, re-insufflation was attempted.It reached setting pressure and sounded alarm.Then, the as-ifs1 could not change to air seal mode.That surgery left only a rectal anastomosis.So, the surgery was completed without changing to air seal mode, with the inner tube still in place." the patient was extubated and does not have any comorbidities.There was no delay to the procedure.This report is being raised on the basis of injury due to subcutaneous emphysema of the patients face.

• 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: 15410219
• MDR Text Key: 299767899
• Report Number: 1320894-2022-00191
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• 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?: Yes
• Date Manufacturer Received: 08/24/2022
• 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; Other
• Patient Ethnicity: Non Hispanic