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 Hemorrhage/Bleeding (1888)

Event Date 07/29/2022

Event Type  Injury  

Event Description

Conmed japan reported on behalf of their customer that the device, as-ifs1, airseal ifs, 110v was being used on (b)(6) 2022 during a robotic-assisted pancreaticoduodenectomy procedure when it was reported ¿the gas replacement alarm sounded while in the air seal mode, and the device switched to the power-on screen during gas switching.Even after switching to new gas, the gas replacement alarm continued to sound, so i prepared a new as main unit to deal with it.After air seal mode on the new as main unit, looking inside the abdominal cavity, it was confirmed that the liver had been damaged with da vinci maryland forceps.The bleeding stopped and the operation ended safely.¿.The procedure was completed with the alternate as-ifs1.There was a 30 minute delay to the procedure.Further assessment found the liver was damaged when the forceps made contact with the liver.The doctor said, ¿the forceps had be sticking in the liver¿.The instruments could not be removed from the access ports when the alarm sounded, "because they used da vinci".The da vinci xi was used and "is complicated to operate.So, it is difficult to remove those instruments soon." energy devices were used to stop the bleeding.It is unknown if there was prolonged hospitalization.The ifs-valve1, valve w/hoses & mtg bracket; asm-evac1, trilumen filtered tube set and ias12-100lpi, airseal 12/100mm lpi port will be listed as concomitant devices; there was no allegation against these devices.This report is being raised on the basis of injury due to bleeding of the liver.

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.

Manufacturer Narrative

Based on the evaluation of the returned airseal unit, it has been determined that the system functioned as designed and alarmed the user of a low gas supply.The user facility reacted during the second gas alarm and attempted to switch the gas valve from initial tank to the second tank; however, the airseal unit continued the countdown to shut down insufflation as it is designed when no more gas flow is available.The unit was returned to conmed japan repair center and after extensive testing, the reported event could not be reproduced.While there were several errors noted during the evaluation and the unit was overdue for preventive maintenance, none of the findings would have contributed to this event.The gas tanks used with the unit were not returned for evaluation and conmed does not supply gas tanks to customers with the airseal system.Although the patient¿s liver was damaged by the da vinci forceps during this event that was associated with the use of the conmed airseal system, the investigation determined that the unit did not cause nor contribute to the reported injury.The service history was reviewed, and no preventative maintenance (pm) service data was found rendering the device overdue for pm.From the serial number, the device was manufactured in 2019.A device history record review was requested from the manufacturer, and no review was communicated.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 1,109,442 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: if the alarm sounds, check for any blockage of the cooling vents.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-ifs1, airseal ifs, 110v was being used on 29jul22 during a robotic-assisted pancreaticoduodenectomy procedure when it was reported ¿the gas replacement alarm sounded while in the air seal mode, and the device switched to the power-on screen during gas switching.Even after switching to new gas, the gas replacement alarm continued to sound, so i prepared a new as main unit to deal with it.After air seal mode on the new as main unit, looking inside the abdominal cavity, it was confirmed that the liver had been damaged with da vinci maryland forceps.The bleeding stopped and the operation ended safely.¿.The procedure was completed with the alternate as-ifs1.There was a 30 minute delay to the procedure.Further assessment found the liver was damaged when the forceps made contact with the liver.The doctor said, ¿the forceps had be sticking in the liver¿.The instruments could not be removed from the access ports when the alarm sounded, "because they used da vinci".The da vinci xi was used and "is complicated to operate.So, it is difficult to remove those instruments soon." energy devices were used to stop the bleeding.It is unknown if there was prolonged hospitalization.The ifs-valve1, valve w/hoses & mtg bracket; asm-evac1, trilumen filtered tube set and ias12-100lpi, airseal 12/100mm lpi port will be listed as concomitant devices; there was no allegation against these devices.This report is being raised on the basis of injury due to bleeding of the liver.

• 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: 15223325
• MDR Text Key: 297859912
• Report Number: 1320894-2022-00176
• 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,Followup
• Report Date: 09/28/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASM-EVAC1, TUBING; ASM-EVAC1, TUBING; DA VINCI XI; DA VINCI XI; ENERGY DEVICES; ENERGY DEVICES; IAS12-100LPI, PORT; IAS12-100LPI, PORT; IFS-VALVE1; IFS-VALVE1
• Patient Outcome(s): Required Intervention; Other
• Patient Ethnicity: Non Hispanic