MAUDE Adverse Event Report: SURGIQUEST, INC. SURIQUEST AIRSEAL; INSUFFLATOR

Model Number AS-IFS1

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 04/14/2015

Event Type  Injury  

Event Description

The company was made aware on (b)(6) 2015 that a patient at (b)(6) presented with tension pneumothorax.The patient was undergoing a robotic hiatal hernia when the condition was discovered.The patients condition resolved without further incident.The device is question is still in use at the facility.No user facility report has been received at the time of this reportage.

Manufacturer Narrative

While the exact cause is unk, in light of what was reported we believe it is highly unlikely that the device was the root cause of the event.During a f/u visit to the hosp our company rep was informed that staff does not believe that the airseal ifs system was the cause of the condition.The system has been employed in over (b)(4) cases and there have been no other reports of tension pneumothorax associated with the use of the system.While we are told that it is unlikely that a user facility report will be submitted to fda, the company has taken a proactive position in reporting to the agency.The company continues to monitor the clinical use of airseal ifs in accordance with the company policy and procedures and works diligently to improve product safety and design as part of the company's commitment to continous improvement.

• Brand Name: SURIQUEST AIRSEAL
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): SURGIQUEST, INC.; milford CT 06460
• Manufacturer Contact: daniel donovan ; 333 quarry rd; milfod, CT 06460 ; 2037131925
• MDR Report Key: 4770911
• MDR Text Key: 5794355
• Report Number: 3006217371-2015-00003
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LAPRASCOPIC TROCAR AND CANNULA,
• Patient Outcome(s): Other
• Patient Age: 54 YR