MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL TRI-LUMEN FILTERED TUBE SET; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number ASM-EVAC

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pulmonary Emphysema (1832); No Consequences Or Impact To Patient (2199)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

The used airseal tri-lumen filtered tube set is not expected to be returned for evaluation, as it was discarded at the user facility after the surgery.As of this filing the investigation remains in process, a supplemental and final report will be filed upon the completion of the complaint investigation.Device was discarded at user facility.

Event Description

The user facility reported that during a gynecology, laparoscopic promontofixation procedure on (b)(6) 2017, the patient was noted to have experienced subcutaneous emphysema and required to remain in the hospital for a longer period than anticipated.As reported, there were no abnormalities noted with the performance of the airseal unit and/or this airseal tri-lumen filtered tube set used during the procedure.The report further stated that the procedure was completed as planned with no surgical or medical intervention required.Additional information received from the user facility via the e-mail from the distributor dated 28-apr-2017 revealed that there was "no medical consequences" with the patient after the event.This report is filed based on the allegation that the patient experienced subcutaneous emphysema and required to remain in the hospital for a longer period than anticipated.This mdr is related to 2 other mdrs #3006217371-2017-00012 and #3006217371-2017-00013.

Manufacturer Narrative

As reported, the used/damaged airseal tri-lumen filtered tube set was discarded at the user facility due to contamination and 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 and/or verified.A review of the device history record for this device could not be performed, as the lot number was not provided.A 2-year review of complaint history shows there have been one other similar report of patient experienced "subcutaneous emphysema" received for this device.During this same time frame, approximately (b)(4) units have been sold worldwide, making the rate of occurrence for this failure mode (b)(4).To date, there has been no patient long term adverse effect resulting from this type of incidents or the use of this device.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.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.In fact, this effect is well known in both robotic surgery and in laparoscopic surgical procedures and is widely reported in many peer-reviewed publications.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.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.

• Brand Name: AIRSEAL TRI-LUMEN FILTERED TUBE SET
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): SEQUEL SPECIAL PRODUCTS; 122 avenue of industry; waterbury CT 06705
• Manufacturer Contact: n. kim grady ; 11311 concept boulevard; largo, FL 33773 ; 7273995479
• MDR Report Key: 6580837
• MDR Text Key: 75603055
• Report Number: 3006217371-2017-00011
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

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?: No
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• 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: 69 YR