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

Model Number AS-IFS1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pneumothorax (2012); Respiratory Failure (2484)

Event Date 12/17/2015

Event Type  Injury  

Manufacturer Narrative

On december 29, 2015 a company representative was made aware of an event which transpired after robotic assisted partial nephrectomy surgery.The patient presented with acute postoperative respiratory failure requiring intubation.A cxr determined a large right pneumothorax, which the physician stated to be likely secondary to barotrauma or operative pneumothorax.The patient fully recovered without further incident and was released from hospital on schedule.No user facility report has been filed to date and the device in question has been employed in surgery post event without issue.No malfunction of the device has been reported.While there is a report of pneumothorax with subsequent intubation, there is no clear evidence to reasonably suggest that the device caused the event.This has also not been suggested by medical staff at the facility.This report is being submitted in accordance with 21 cfr 803 due to the medical intervention that ensued post event.The airseal ifs is a laparoscopic access system intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke.Laparoscopic procedures and robot assisted procedures have long been associated with thoracic complications including pneumothorax.Literature on pneumothorax after laparoscopic and robot assisted surgery is voluminous and concludes that there are many and various reasons why this condition presents itself.Morbid obesity, large tumors, inflammatory intestinal pathologies, previous surgeries and chemotherapy are some of the factors that can facilitate the occurrence of diaphragmatic lesions.Additionally, the physician indicated that the event may have been caused by barotrauma.Barotrauma occurs in a small percentage of patients undergoing mechanical ventilation.Common consequences include pneumothorax.Small uncomplicated pneumothorax can heal on their own and chest tube insertion is a normal procedure in large pneumothorax.In this case, post chest tube insertion, the patient recovered and was released from hospital as scheduled.No further issues have been reported.While the exact cause is unknown, based on the information provided, we believe it to be unlikely that the device caused the event.The system is still in use at the facility and no issues have been reported.The company continues to monitor the clinical use of airseal ifs and works diligently to ensure product safety.

Event Description

On december 29, 2015 , surgiquest inc.Became aware of an event, which transpired on (b)(6) 2015, involving a female patient, (b)(6).Post robot-assisted partial nephrectomy for removal of renal ca mass, the patient suffered acute postoperative respiratory failure requiring intubation.A cxr noted a large right pneumothorax, which the physician deemed likely secondary to barotrauma or operative pneumothroax.The patient recovered and was released from the hospital and no further complications were noted.The device in question is still in use at the facility and no issues with the device have been noted.No user facility report has been filed as of the date of this report.

• Brand Name: SURGIQUEST AIRSEAL
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): SURGIQUEST, INC; 488 wheelers farms road; milford CT 06461
• Manufacturer Contact: ms calzetta ; 488 wheelers farms road; milford, CT 06461 ; 2037992400
• MDR Report Key: 5398829
• MDR Text Key: 37112456
• Report Number: 3006217371-2016-00001
• Device Sequence Number: 1
• Product Code: HIF
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2015

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: Physician
• Device Model Number: AS-IFS1
• Device Catalogue Number: AS-IFS1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2015
• Initial Date FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 87