MAUDE Adverse Event Report: W.O.M WORLD OF MEDICINE GMBH AIRSEAL INSUFFLATION UNIT

Catalog Number AS-IFS 2

Device Problem Pressure Problem (3012)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/10/2019

Event Type  Injury  

Manufacturer Narrative

The product is not expected to be returned, however the complaint investigation is ongoing.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The conmed representative reported on behalf of their facility that the as-ifs2, airseal unit, potentially caused subcutaneous emphysema in a patient during a laparoscopic prostatectomy on (b)(6) 2019.It is reported that the nursing staff was trying to get the intraabdominal pressure to 20mmhg and was having trouble doing so.The pressure finally reached 20mmhg but only after multiple attempts of tapping the "up" arrow.The patient's procedure was a long procedure, the patient's co2 in the blood had increased enough that a medical emergency was called due to the patient becoming less responsive during the evening and the anesthesiologist decided to send the patient to the icu.During recovery the anesthesiologist reported that the patient's co2 level was at the top end of normal, the patient's co2 level continued to rise post operatively due to unknown circumstances.The current status of the patient is "up and walking and talking".There seems to be no adverse effect.The procedure was completed, there was no delay in surgery.The subcutaneous emphysema was diagnosed via ct scan by the surgeon.This report is being raised as patient injury due to patient being sent to icu.

Manufacturer Narrative

An evaluation of the returned device found no fault.The unit has been tested.The unit was calibrated to specification and put on a 12-hour test run.The unit was final tested and met all specifications.No fault found.The service history was reviewed and no data was found.A request for the dhr was made but has not been received.A two-year review of complaint history revealed there has been 4 complaints regarding 4 devices for this device family and failure mode.During the same time frame (b)(4).Per the instructions for use, the user is advised the following; failure to properly follow the instructions for use can lead to serious surgical consequences.Higher insufflation pressures (>15 mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumotrorax, pneumoscrotum and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL INSUFFLATION UNIT
• Type of Device: INSUFFLATION UNIT
• Manufacturer (Section D): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin, 10587 ; GM 10587
• MDR Report Key: 9315476
• MDR Text Key: 185661691
• Report Number: 3006217371-2019-00396
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K172516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other