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

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.

• Brand Name: AIRSEAL TRI-LUMEN FILTERED TUBE SET
• Type of Device: LAPAROSCOPE, 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 Key: 6687144
• MDR Text Key: 79086538
• Report Number: 3006217371-2017-00017
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

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 Number: ASM-EVAC
• Device Lot Number: 27616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 08/24/2017
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: AS-IFS1 AIRSEAL IFS 110V SERIAL #(B)(4)
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 64