MAUDE Adverse Event Report: W.O.M WORLD OF MEDICINE GMBH AIRSEAL IFS, 230V; INSUFFLATION UNIT

Catalog Number AS-IFS2

Device Problems Ambient Temperature Problem (2878); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Death (1802); Hypothermia (1915)

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, date of the death is unknown.The reported device is being returned to conmed for evaluation and the complaint investigation is on-going.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported the as-ifs2 was involved in a patient death.The as-ifs2, airseal unit was used in a laparoscopic anterior resection procedure.The patient expired post surgery due to cardiac complications attributed to hypothermia.At this time information is still being gathered and the investigation is still underway.This report is being raised based on patient death.

Manufacturer Narrative

Correction: previously stated patient death, further investigation found patient is alive and well.Misinformation was provided by the original reporter.Previously stated death, this filing is for a malfunction due to new information that patient made a full recovery.Previous patient code (b)(4), previous device code (b)(4) evaluation: complaint not confirmed.Evaluation of the device found that it passed all tests per the annual inspection guide and the fluke biomedical (b)(4) test and inspection procedure; no fault found.The service history was reviewed, and no data was found.Per the vendor, the manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product, no abnormalities were found.A two-year review of complaint history revealed there has been 3 complaints regarding 3 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4) per the instructions for use, the user is advised the following; - failure to properly follow the instruction 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 this issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

As-ifs2, airseal unit was used in a laparoscopic anterior resection procedure.Initially, the patient, was reported as having expired post-surgery due to cardiac complications attributed to hypothermia.At this time information is still being gathered and the investigation is still underway.Additional information was received on 4/16/19 stating the report of patient death was an error, patient did have some cardiac issues during the case due to hypothermia, however patient had a full and positive recovery.

• Brand Name: AIRSEAL IFS, 230V
• Type of Device: INSUFFLATION UNIT
• Manufacturer (Section D): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin, 10587 ; GM 10587
• Manufacturer Contact: melanie hansen ; 11311 concept blvd.; largo, FL 33773
• MDR Report Key: 8474211
• MDR Text Key: 140783418
• Report Number: 3006217371-2019-00099
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/06/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death