• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL IFS, 110 V LAPAROSCOPE, GENERAL & PLASTIC SURGERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONMED CORPORATION AIRSEAL IFS, 110 V LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number AS-IFS1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969)
Event Date 06/07/2017
Event Type  Injury  
Manufacturer Narrative

As reported, the airseal ifs, 110v unit is not expected for evaluation, as it remains in use to date at the user facility with no issues reported. As of this filing, the investigation remains in progress, a supplemental and final report will be filed upon the completion of the complaint investigation. Device remains in use at user facility.

 
Event Description

The user facility reported that during a robotic lap hysterectomy, the airseal ifs unit and the airseal tri-lumen filtered tube set were used to insufflate the patient through an ethicon xcel 12x150mm trocar at the umbilicus site. The ethicon trocar was a direct approach without use of camera or first insufflating through verress needle. Insufflation was set at 15mm and low flow and was turned on and pneumo was created without adjusting the flow or pressure. Once at desired pressure, a second trocar (robotic 8mm trocar) was placed into the patient. Seconds after the robotic trocar was placed, the patient appeared to have a heart attack and flatlined. The patient was resuscitated and was taken to the icu via the hospitals protocols. The procedure was therefore aborted. To date, there has been no additional information received regarding the patient latest condition or any indication that a long term adverse effect has occurred. This report is filed based on the allegation that the surgery was aborted due to patient experienced heart attack, which required resuscitation and admission to the icu. This mdr is related to one other mdr #3006217371-2017-00017.

 
Manufacturer Narrative

As stated in the initial report, the device remains in use at the facility and was not returned to conmed for evaluation. A historical complaint review found no prior similar complaints for this device or reported issue. The service record for this device shows no prior history. This device complaint was unable to be confirmed. The reported issue does not identify a failure mode for the device, but rather states the device was in use when the patient suffered cardiac arrest. There is no evidence that the airseal device caused or contributed to this patient injury. This incident type will continue to be monitored through the complaint system.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAIRSEAL IFS, 110 V
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
CONMED CORPORATION
525 french road
utica NY 13502 5994
Manufacturer (Section G)
W.O.M. WORLD OF MEDICINE
4531 36th street
orlando FL 32811
Manufacturer Contact
lindsey sheppard
525 french road
utica, NY 13502-5994
7273995209
MDR Report Key6687127
MDR Text Key79071745
Report Number3006217371-2017-00016
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK143404
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2017
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
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/15/2017
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
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/05/2017 Patient Sequence Number: 1
Treatment
ASM-EVAC AIRSEAL TRI-LUMEN TUBE SET, LOT #27616
-
-