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 Hypothermia (1915)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.The service history review cannot be conducted as a serial number was not provided.A device history record (dhr) review cannot be conducted as a serial number was not provided.(b)(4).Per the instructions for use, the user is advised the following: the gas flow can lead to a lowering of the patient¿s body temperature during insufflation.Hypothermia during insufflation can cause heart and cardiovascular problems.To reduce this risk, minimize high gas flows due to large leaks, the use of cold irrigation and infusion solutions.Always monitor the patient¿s body temperature during the entire surgical procedure.The insufflation gas flow usually drops significantly after the target pressure has been reached and it is then only required to maintain the abdominal pressure.However, leaks within the abdomen or the instrument can lead to a constant gas flow of above 1 l/min.When operating on children younger than 12, a gas flow of more than 1 l/min poses an increased risk of hypothermia for the patient.Corresponding measures to prevent hypothermia include the use of blankets or pre-warmed gas.The patient¿s body temperature has to be monitored at all times during surgery.We will continue to monitor for trends 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 (b)(6) 2024 during a robotic-assisted endoscopic colorectal resection and ¿it was reported that the patient experienced hypothermia while using the air seal.¿.Further assessment found that the procedure was completed without a delay.There was no medical/surgical intervention or prolonged hospitalization for the patient.This report is being raised on the basis of injury due to device, with no report of malfunction, being used during a procedure where the patient experienced hypothermia.

• 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: 18720571
• MDR Text Key: 335575715
• Report Number: 1320894-2024-00035
• 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: 02/16/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/16/2024
• 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): Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic