MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AS-IFS1; AIRSEAL CAPITAL

Catalog Number AS-IFS1

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Code Available (3191)

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

The reported device was returned to conmed for evaluation.Functional testing was performed by way of running the unit for over thirty minutes in airseal mode at 15 mmhg.The unit met specifications and performed as intended.The serial number shows this device was manufactured in 2015.The service history was reviewed and no relationship to this complaint was found.A two-year review of complaint history revealed 11 similar complaints for this device family and failure mode.There has been a total of 2 adverse events reported for the device family for this failure mode in the same timeframe.A risk analysis was performed and found this failure mode and occurrence level to be consistent and acceptable with current risk documents.The instructions for use advise the user of the following.Only the physician can evaluate the clinical factors involved with each patient and determine if the use of this device is indicated.The physician must determine the specific technique and procedure that will accomplish the desired clinical effect.The functional test must be performed prior to each surgery.Because the functional test is performed during initial startup, the unit must be power cycled (off/on) prior to each surgery.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The conmed sales representative reported on behalf of the user facility that during a hysterectomy, the as-ifs1 unit would lose pressure intermittently.There were no error/codes from the unit at that time.The doctor converted the procedure to open due to the pressure not maintaining once mode switched to standard insufflation.The length of the procedure was extended due to opening the patient, as well as, additional checking for bowel obstructions.Upon gathering additional information, after the procedure was converted it was completed with no further incidents.The patient has been discharged and is recovering as expected.Although no patient injury was reported, this report is being raised on the basis of a procedure being converted from laparoscopic to open.

• Brand Name: AS-IFS1
• Type of Device: AIRSEAL CAPITAL
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• 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: 7332232
• MDR Text Key: 102157884
• Report Number: 3006217371-2018-00049
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other