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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; INSUFFLATOR, LAPAROSCOPIC

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W.O.M. WORLD OF MEDICINE GMBH AIRSEAL IFS, 110V; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Catalog Number AS-IFS1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Air Embolism (1697)
Event Date 07/16/2022
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.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
Conmed (b)(4) reported on behalf of the customer that the as-ifs1, airseal ifs, 110v was being used on (b)(6) 2022 during a robotic assisted laparoscopic radical prostatectomy procedure when it was reported ¿the patient became infected with subcutaneous emphysema after the operation and is currently taking medication.¿ further assessment found "no device failures reported.¿ the procedure was completed with a no report of delay.Medical intervention was required for the patient and received medication to treat the subcutaneous emphysema.It is unknown if there was extended hospitalization for patient and current status of the patient is unknown.This report is being raised on the basis of injury due to subcutaneous emphysema.This report is being raised on the basis of injury due to subcutaneous emphysema.
 
Manufacturer Narrative
Reported event of subcutaneous emphysema is inconclusive.The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A device history review was not conducted as the device has been in the field more than 12 months.The service history was reviewed, and no data was found.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding 5 devices, 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 ifu, incorrect placement of a cannula or a trocar into subcutaneous tissue may lead to emphysema.To reduce the risk, use a low gas flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned.Long surgeries (> 200 min.), the use of many access points, duration and size of leaks at these points may also contribute to emphysema.Be sure to close leakages in trocar access points immediately.Additionally, higher insufflation pressures (> 15 mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
Conmed japan reported on behalf of the customer that the as-ifs1, airseal ifs, 110v was being used on 16jul22 during a robotic assisted laparoscopic radical prostatectomy procedure when it was reported ¿the patient became infected with subcutaneous emphysema after the operation and is currently taking medication.¿ further assessment found "no device failures reported.¿ the procedure was completed with a no report of delay.Medical intervention was required for the patient and received medication to treat the subcutaneous emphysema.It is unknown if there was extended hospitalization for patient and current status of the patient is unknown.This report is being raised on the basis of injury due to subcutaneous emphysema.
 
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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 Key15192910
MDR Text Key297534763
Report Number1320894-2022-00173
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K190303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/12/2022
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 NumberAS-IFS1
Device Lot Number1908CE0654
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/22/2022
Initial Date FDA Received08/09/2022
Supplement Dates Manufacturer Received08/23/2022
Supplement Dates FDA Received09/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient EthnicityNon Hispanic
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