MAUDE Adverse Event Report: W.O.M. - WORLD OF MEDICINE AIRSEAL IFS, 110V

Catalog Number AS-IFS1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hypothermia (1915)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

The used device was returned to conmed for repair evaluation.The evaluation found that the device had a burnt fuse and fuse holder.The device was repaired and the unit was calibrated.Subsequently, the device passed all functional tests.The evaluation of the device could not determine the customer reports for hypothermia.This device is not manufactured by conmed, therefore; a review of the manufacturing documents was unable to be completed.Based on the serial number, this device was manufactured in 2014.A historical review of complaint data revealed one complaint for this failure in the past two years.In that same time frame, (b)(4) units were sold worldwide, making the occurrence rate for this failure (b)(4).The instructions for use (ifu) advise the user of the following: - hypothermia/monitoring body temperature.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.- failure to properly follow the instructions for use can lead to serious surgical consequences.- only qualified physicians with knowledge, experience and training in laparoscopic techniques should use the components of the airseal access system.- these instructions for use do not include descriptions or instructions for surgical techniques or laparoscopic procedures.It is the responsibility of the physician performing any procedure to determine the appropriateness of the type of procedure to be performed with the use of these products and to determine the specific technique for each patient.Due to severity of the reported patient injury, an investigation has been initiated.The reported problem will continue to be monitored via the complaint system.

Event Description

The user facility reported that despite preoperative warming, a patient experienced hypothermia during use of an airseal ifs, 110v.The patient's temperature dropped from 36.4 degrees celsius to 35.4 degrees celsius.The patient did not meet normothermia requirements at 36 degrees celsius for recovery.To date, no patient status information has been provided.This report is raised on the basis of a reported patient injury.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: AIRSEAL
• Manufacturer (Section D): W.O.M. - WORLD OF MEDICINE; 4531 36th street; orlando FL 32811
• Manufacturer (Section G): W.O.M. - WORLD OF MEDICINE; 4531 36th street; orlando FL 32811
• Manufacturer Contact: ann lee ; 11311 concept boulevard; largo, FL 33773 ; 7273995421
• MDR Report Key: 6906576
• MDR Text Key: 87847873
• Report Number: 3006217371-2017-00090
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2017

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR