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

Model Number AS-IFS

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Date 02/17/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, a company rep was made aware of a reported case of subcutaneous emphysema at (b)(6) medical center.The pt was readmitted with right leg pain and swelling the day following the surgery, (b)(6).Subcutaneous emphysema (sce) was detected by x-ray.The condition resolved itself and the pt was discharged 24 hours later on (b)(6).There was no further injury to the pt as a result of the condition nor was further medical or surgical intervention required.The pt has been seen back in the office since and there are no further complications other than the reported post-operative pain.No user facility report has been received to date.

Manufacturer Narrative

Summary and conclusions: on (b)(4) 2015, a company representative was made aware of a reported case of subcutaneous emphysema at (b)(6) medical center.The surgiquest airseal ifs system was in use at the time of the event.The system is a laparoscopic access system (insufflation system) used to create a path of entry for minimally invasive surgery and is cleared under 510(k) [k103692].No user facility report has been received at the time of this submission.The company representative did follow up and returned to the hospital to conduct an interview with the surgeon.The patient was a female.(b)(6).The procedure was a robotic hysterectomy with sacrocolpopexy with sling performed on (b)(6).There were a significant number of ports deployed during the procedure (5).While the duration of this procedure is unknown, the srals (supracervical robotic-assisted laparoscopic surgery) procedure is typically of long duration (>3 hrs).The patient was readmitted with right leg pain and swelling the following day, (b)(6).Subcutaneous emphysema (sce) was detected by x-ray.The condition resolved itself and the patient was discharged 24 hours later on (b)(6).There was no further injury to the patient as a result of the condition nor was further medical or surgical intervention required.The patient has been seen back in the office since and there are no further complications other than the reported post-operative pain.The system was not returned for evaluation and is still in use at the hospital.There is no reason to believe there was a malfunction of any sort.Co2 is the preferred insufflation gas used in minimally invasive or laparoscopic surgery.The pressurization of the gas in to the subcutaneous tissue is commonly referred to as subcutaneous emphysema.Subcutaneous emphysema following laparoscopic procedures is a well-recognized risk.This specific effect is a known effect in all minimally invasive surgical procedures and not unique to surgery performed with the airseal system.This effect, in fact, is well known in both robotic surgery and in laparoscopic surgical procedures.Many cases of subcutaneous emphysema go unreported as the condition is typically sub-clinical and is usually of no lasting negative consequence.The condition typically clears on its own with no harm or serious injury done to the patient and therefore many incidences either are not reported by the surgeon or do not rise to the level of a reportable event in accordance with the cfr [21 cfr part 803].In this case, the patient complained of post-operative pain and was readmitted for twenty-four hours, so this reportage is being submitted upon awareness of the event.Additionally, there are many published known causes and contributing independent risk factors with regard to subcutaneous emphysema.Srals, in particular and according to published literature, has extensive subcutaneous emphysema associated with the procedure.Among the known causes are use of a veress needle resulting in accidental extraperitoneal insufflation, port placement where the port does not actually extend in to the abdomen and therefore pressurized gas is forced between tissue layers, unintentional "pull-back'" of the port during surgery causing the pressurized gas to be forced into tissue layers, the number of ports used, angle of the port insertion, repeated dislodging and reinsertion of the surgical ports enlarging the wound or creating new tissue paths into which the gas can flow.Higher insufflation pressure settings, duration of the surgery, age of the patient, patient bmi (body mass index), and peritoneal vs.Extraperitoneal and preperitoneal surgical procedures, both of the latter which carry a known higher risk.In the sarls procedure reported here, there were a high number of trocars (5) employed, robot assisted technique which intrinsically limits haptic feedback, a long surgery duration, extraperitoneal access and opening of the peritoneum down to the pelvis (based on the known procedure) and a patient with a very low body mass index (bml= 21.3).All of these factors are well-documented contributors to the creation of sce.Finally and in conclusion, the pressurization of the co2 into the subcutaneous tissue is a known risk in minimally invasive surgery and this condition is not unique to the surgiquest airseal ifs system.The system has not been returned and the ifs unit is still in use.Based on what was reported to the company, there is no reason to believe that there was a device malfunction nor was there death or serious injury to the patient in accordance with terms and definitions set forth in 21 cfr part 803, "medical device reporting" and fda guidance, ''medical device reporting for manufacturers, {july 9, 2013]." again, the patient's condition cleared on its own and she was discharged without further incident.The company does not know whether or not a user facility report will be filed but has taken a proactive stance in reporting to fda.The company continues to monitor the clinical use of airseal in accordance wi th the standards and works diligently to improve product safety and design as part of our commitment to continuous improvement.

• Brand Name: SURGIQUEST AIRSEAL
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): SURGIQUEST, INC.; 333 quarry rd; milford CT 06460
• Manufacturer Contact: daniel donovan ; 333 quarry rd; milford, CT 06460 ; 2037131925
• MDR Report Key: 4600508
• MDR Text Key: 5464835
• Report Number: 3006217371-2015-00002
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AS-IFS
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• 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
• Patient Sequence Number: 1
• Treatment: CANNULA; LAPAROSCOPIC TROCAR
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Weight: 62