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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.O.M WORLD OF MEDICINE GMBH AIRSEAL IFS 110V; INSUFFLATION UNIT

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W.O.M WORLD OF MEDICINE GMBH AIRSEAL IFS 110V; INSUFFLATION UNIT Back to Search Results
Catalog Number AS-IFS1
Device Problem No Apparent Adverse Event (3189)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
The report device is being returned to conmed for evaluation.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
Conmed (b)(4) reported on behalf of their customer that the as-ifs1, airseal unit was used in a laparoscopic partial hepatectomy on unknown date, where the patient had a hole in the hepatic artery.The air seal pressure setting was 8mmhg.The doctor closed since the patient saturation has been decreased and found out there was a hole on hepatic artery.After the closing the hole the saturation was improved.After the 2 to 3 days from the surgery a deep vein thrombotic symptom has been observed.The doctor commended there is no evidence that this symptom has causal relationship to air seal.There is no indication that the airseal unit malfunctioned in any way.There is no actual complaint against the airseal, just that it was used in this procedure.Additional information and investigation has been requested but to date has not been received.As this was reported to the (b)(6) by conmed (b)(4), we are filing to the fda.
 
Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.Additionally, there is no reported allegation of device malfunction.The service history was reviewed, and no data was found.As the device has been in the field for more than 12 months, the dhr was not reviewed.(b)(4).Per the instructions for use, the user is advised the following; insufflation of co2 should be done carefully and while monitoring the patient's response.The user, particularly the anesthetist, should be informed about possible cardiovascular and respiratory problems of the patient and monitor these intra-operatively.Improper placement of the insufflation instrument could cause gas penetrating a vessel or an integral organ, resulting in gas embolisms.To reduce this risk, use a low flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned.Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value.Gas embolisms can also be caused by a high intra-abdominal pressure.Avoid high pressure settings and close damaged blood vessels at once.Additionally, conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.
 
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Brand Name
AIRSEAL IFS 110V
Type of Device
INSUFFLATION UNIT
Manufacturer (Section D)
W.O.M WORLD OF MEDICINE GMBH
salzufer 8
4th floor
berlin, 10587
GM  10587
MDR Report Key9545313
MDR Text Key183305122
Report Number3006217371-2019-00436
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
PMA/PMN Number
K172516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberAS-IFS1
Was Device Available for Evaluation? No
Date Manufacturer Received01/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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