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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL TRI-LUMEN FILTERED TUBE SET LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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CONMED CORPORATION AIRSEAL TRI-LUMEN FILTERED TUBE SET LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number ASM-EVAC
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969)
Event Date 06/07/2017
Event Type  Injury  
Manufacturer Narrative

The used airseal tri-lumen filtered tube set is not expected to be returned for evaluation, as it was discarded at the user facility after the cancellation of the procedure. As of this filing the investigation remains in process, a supplemental and final report will be filed upon the completion of the complaint investigation.

 
Event Description

The user facility reported that during a robotic lap hysterectomy, the airseal tri-lumen filtered tube set with the as-ifs unit were used to insufflate the patient through an ethicon xcel 12 x 150 mm 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 15 mm 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 8 mm 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 a heart attack, which required resuscitation and admission to the icu. This mdr is related to one other mdr #3006217371-2017-00016.

 
Manufacturer Narrative

As stated in the initial report, the device was discarded by the user facility after the surgery was canceled. An evaluation was unable to be performed. A historical complaint review found no prior similar complaints for this device or reported issue. 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.

 
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Brand NameAIRSEAL TRI-LUMEN FILTERED TUBE SET
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
CONMED CORPORATION
525 french road
utica NY 13502 5994
Manufacturer (Section G)
SEQUEL SPECIAL PRODUCTS
122 avenue of industry
waterbury CT 06705
Manufacturer Contact
lindsey sheppard
525 french road
utica, NY 13502-5994
7273995209
MDR Report Key6687144
MDR Text Key79086538
Report Number3006217371-2017-00017
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 NumberASM-EVAC
Device LOT Number27616
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? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/05/2017 Patient Sequence Number: 1
Treatment
AS-IFS1 AIRSEAL IFS 110V SERIAL #(B)(4)
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