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

Catalog Number AS-IFS1

Device Problem Gas Output Problem (1266)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/11/2024

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

Event Description

Conmed japan reported on behalf of the customer that as-ifs1, airseal ifs, 110v, was being used during a robot-assisted laparoscopic partial nephrectomy procedure on (b)(4)2024 when it was reported ¿damage to organs occurred due to prolonged exclusion.The set pressure of the air seal changed from 12 to 20 mmhg without my knowledge and remained at 20 mmhg until the end of pneumoperitoneum.As of now, the patient's condition has been confirmed up to the point where he was transferred to the icu, but the patient's condition after that is unknown.As for the hospitalization period, the patient's condition is improving steadily, and it is expected that the patient will be discharged within the scheduled period.¿.It was confirmed that the operating room staff had their elbows resting on the air seal body and their hands were close to the lcd panel for a long time, which may have caused the pneumoperitoneum pressure settings to change.Further assessment questioning found that ¿when asked what is meant by prolonged exclusion the reporter said, "this indicates that the organ has been compressed for a long period of time.".The procedure was completed without delay.This report is being raised on the reported injury due to the patient¿s organs being compressed and extended hospitalization to the icu.

Manufacturer Narrative

The device will not be 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 (dhr) was requested and to date, a response was not received; therefore, a review cannot be conducted.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, 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 (b)(4).Per the instructions for use, the user is advised the manufacturer is not liable for direct or consequential damages, and the warranty becomes null and void if the device and/or the accessories are improperly used, prepared, or maintained; the instructions and rules in the instructions for use are not adhered to.The functional test must be performed prior to each surgery.Because the functional test is performed during initial start up, the unit must be power cycled (off/on) prior to each surgery.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

Conmed japan reported on behalf of the customer that as-ifs1, airseal ifs, 110v, was being used during a robot-assisted laparoscopic partial nephrectomy procedure on (b)(6) 2024 when it was reported ¿damage to organs occurred due to prolonged exclusion.The set pressure of the air seal changed from 12 to 20 mmhg without my knowledge and remained at 20 mmhg until the end of pneumoperitoneum.As of now, the patient's condition has been confirmed up to the point where he was transferred to the icu, but the patient's condition after that is unknown.As for the hospitalization period, the patient's condition is improving steadily, and it is expected that the patient will be discharged within the scheduled period¿.It was confirmed that the operating room staff had their elbows resting on the air seal body and their hands were close to the lcd panel for a long time, which may have caused the pneumoperitoneum pressure settings to change.Further assessment questioning found that ¿when asked what is meant by prolonged exclusion the reporter said, "this indicates that the organ has been compressed for a long period of time".The procedure was completed without delay.This report is being raised on the reported injury due to the patient¿s organs being compressed and extended hospitalization to the icu.

• 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: 18994507
• MDR Text Key: 338889854
• Report Number: 1320894-2024-00084
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Ethnicity: Non Hispanic