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 Type  Injury  

Event Description

In the 37th annual meeting of the japanese society of urological endoscopy and robotics preview on 13nov23, pertaining to experience with gas embolism during robot-assisted partial nephrectomy referencing the as-ifs1, airseal ifs, 110v device it was reported, "a 56-year-old man underwent robot-assisted partial nephrectomy for a 23 x 20 mm diameter tumor on the dorsal side of the lower pole of the right kidney.When the renal gland was incised, there was a sudden drop in spo2 and etco2, and st changes were detected on the electrocardiogram monitor.Diagnosed as gas embolism due to pneumoperitoneum, the pneumoperitoneum pressure was lowered to 10 mmhg and surgery continued.At the end of the surgery, transthoracic echocardiography revealed a small amount of air bubbles remaining in the left ventricular cavity.The patient was extubated in the operating room, and there was no disturbance of consciousness or paralysis of the limbs, and the patient was managed in the intensive care unit.The patient was discharged from the intensive care unit on the third postoperative day without recurrence of convulsions.The visual impairment gradually improved, and the patient was discharged from the hospital on the 8th postoperative day without any neurological sequelae.A later examination revealed that the foramen ovale was patent, and it was thought that a temporary neurological disorder had occurred due to gas inflow into the left heart system.".The discussion does not indicate a malfunction of the device.This report is being raised on the basis of injury due to gas embolism.

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.We will continue to monitor for trends through the complaint system to assure patient.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The service history review cannot be conducted as a serial number was not provided.A device history record review cannot be conducted as a serial number was not provided.(b)(4).Per the instructions for use, the user is advised that improper placement of the insufflation instrument could cause gas penetrating a vessel or an internal organ, resulting in gas embolisms.To reduce the risk, use a low flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned.Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value.Gas embolisms can also be caused by a high intra-abdominal pressure.Avoid high-pressure settings and close damaged blood vessels at once.We will continue to monitor for trends through the complaint system to assure patient.

Event Description

In the 37th annual meeting of the (b)(6) preview on (b)(6) 2023, pertaining to experience with gas embolism during robot-assisted partial nephrectomy referencing the as-ifs1, airseal ifs, 110v device it was reported, "a 56-year-old man underwent robot-assisted partial nephrectomy for a 23 x 20 mm diameter tumor on the dorsal side of the lower pole of the right kidney.When the renal gland was incised, there was a sudden drop in spo2 and etco2, and st changes were detected on the electrocardiogram monitor.Diagnosed as gas embolism due to pneumoperitoneum, the pneumoperitoneum pressure was lowered to 10 mmhg and surgery continued.At the end of the surgery, transthoracic echocardiography revealed a small amount of air bubbles remaining in the left ventricular cavity.The patient was extubated in the operating room, and there was no disturbance of consciousness or paralysis of the limbs, and the patient was managed in the intensive care unit.The patient was discharged from the intensive care unit on the third postoperative day without recurrence of convulsions.The visual impairment gradually improved, and the patient was discharged from the hospital on the 8th postoperative day without any neurological sequelae.A later examination revealed that the foramen ovale was patent, and it was thought that a temporary neurological disorder had occurred due to gas inflow into the left heart system." the discussion does not indicate a malfunction of the device.This report is being raised on the basis of injury due to gas embolism.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18275731
• MDR Text Key: 329846160
• Report Number: 1320894-2023-00262
• 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,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic