MAUDE Adverse Event Report: SEQUEL SPECIAL PRODUCTS AIRSEAL 12/120MM LPI PORT; AIRSEAL CANNULA

Catalog Number IAS12-120LPI

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

Patient Problem Pneumothorax (2012)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation by the user facility, therefore; the reported failure could not be verified and a root cause cannot be determined.A review of the manufacturing documents was unable to be performed since no lot number was provided.A two-year review of complaint history revealed no other similar complaints for this product family and failure mode.In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this confirmed failure (b)(4) percent.No failure mode was reported for this device by the user facility.The conmed representative was present during the case and reported that the device did no exhibit a malfunction during this procedure, therefore; a risk analysis was unable to be conducted due to lack of a failure mode of the device.The instructions for use advises the user of the following.- failure to properly follow the instructions for use can lead to serious surgical consequences.Only qualified physicians with knowledge, experience and training in laparoscopic techniques should use the components of the airseal access system.- it is the responsibility of the physician performing any procedure to determine the appropriateness if the type of procedure to be performed with the use of these products and to determine the specific technique for each patient.- the possibility of air entrainment exists under the following conditions: severe pressure applied externally to the abdomen.Severe and protracted leaking through other traditional ports in place or an open incision.Severe and prolonged suction.- during the conditions described above, the displacement of the insufflation gas with air is temporary and the entrained air will be displaced with co2.- once partial entry has been accomplished, very little pressure is required to complete entry.Excessive pressure may cause injury to intra-abdominal or intra-thoracic structures.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The user facility reported that post robotic assisted hiatal hernia surgery with the use of ias12-120lpi, with a set pressure of 15mmhg and approximately 30 minutes at 10mmhg, the patient suffered from bi-lateral pneumothorax.This led to a 2-day prolonged hospital stay and supplemental oxygen therapy.Upon gathering additional information from the surgeon, the patient was discharged home and the pneumothorax resolved in 2 weeks.This report is raised on the basis of a reported patient injury.

• Brand Name: AIRSEAL 12/120MM LPI PORT
• Type of Device: AIRSEAL CANNULA
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 1 hillside dr; wolcott CT 06716
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502
• Manufacturer Contact: martha camacho urribarri ; 525 french road; utica, NY 13502 ; 3156243051
• MDR Report Key: 7274482
• MDR Text Key: 100202134
• Report Number: 3006217371-2018-00024
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2018

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: Other
• Device Catalogue Number: IAS12-120LPI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/15/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 61 YR
• Patient Weight: 80