MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL TRI-LUMEN FILTERED TUBE SET; INSUFFLATOR, LAPAROSCOPIC

Catalog Number ASM-EVAC

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Emphysema (1832)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

As reported, the used airseal tri-lumen filtered tube set was discarded at the user facility and therefore will not be returned for evaluation.Without the actual product, an evaluation could not be performed and the root cause of the reported subcutaneous emphysema was not able to be determined.However, based on information received from the user facility, which indicated that the procedure was well over 4 hours long and the patient was repositioned in mid case and that either of the two factors could have caused or contributed to this reported incident.In addition, there are many factors that contribute to a higher risk for subq.Specifically, patient demographics such as older age (>65), low bmi (<25), procedure times greater than 200 minutes, five or more port sites, and procedures in the retroperitoneal space (which sacrocolpopexy does).This patient and this type of procedure included all of these risk factors.A review of the device history record could not be performed, as the lot number was not provided by the user facility.(b)(4).This is an isolated incident.The reported problem will continue to be monitored via the complaint system to ensure product safety.No further action is planned at this time.This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable.The airseal ifs system is 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.It is indicated to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it by creating and maintaining a gas sealed, obstruction free path and by evacuating surgical smoke.To reduce the risk of patient injury, the as-ifs instructions for use (ifu) provides the following warnings: 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.These instructions for use do not include descriptions or instructions for surgical techniques or laparoscopic procedures.It is the responsibility of the physician performing any procedure to determine the appropriateness of the type of procedure to be performed with the use of these products and to determine the specific technique for each patient.Device was discarded at user facility.

Event Description

The customer reported that during use of the airseal tri-lumen filtered tube set and the airseal 12mm access port in a robotic hysterectomy/sacrocolpopexy procedure on (b)(6) 2016, the patient experienced post-operative subcutaneous emphysema and required admission to the icu.Received information from the user facility indicated that this was a very long procedure and that it took well over 4.5 hours to complete.It was also reported that the patient's position was changed in the middle of the case and that either of these factors can be a contributing factor to the reported post-op subcutaneous emphysema.Other than the report of patient was being admitted to the icu, there was no other serious injury reported.To date, there has been no additional information received regarding the patient's latest condition or any indication that a long term adverse effect has occurred.

• Brand Name: AIRSEAL TRI-LUMEN FILTERED TUBE SET
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): SURGIQUEST, INC.; 488 wheelers farms road; milford CT 06461
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5882962
• MDR Text Key: 52330909
• Report Number: 3006217371-2016-00029
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/17/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR