MAUDE Adverse Event Report: W.O.M WORLD OF MEDICINE GMBH AIRSEAL IFS UNIT 110V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number AS-IFS1

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

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.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

Conmed (b)(4) received notice from the facility of reported issues with the as-ifs1, airseal ifs unit, serial # (b)(4).(b)(6) hospital, (b)(6) reported the as-ifs1 unit, serial # (b)(4), on an unreported date, was being used during a robotic-assisted distal gastrectomy involving an (b)(6) year old female.It was noticed that the patient's vital signs and respiratory condition worsened during the surgery.The insufflation was stopped.Based on a discussion with the anesthesiologist, pneumothorax was suspected.The surgical approach was changed to open surgery and completed with a 30-minute delay.The hospitalization was prolonged for 5 days because the surgical approach changing to open surgery, however the patient was discharged without any problem.It was noted there were no issues noticed with the as-ifs unit, tubing or port prior to the issue reported and the hospital is using this airseal unit routinely.Although requested, no other information or incident details have been made available by the facility.This mdr reporting is being raised on the basis of injury for the unplanned conversion to an open surgical procedure.

Manufacturer Narrative

D10: details of additional devices used with the airseal are unknown as is the date of event.Investigation of the customer's reported issue and complaint was inconclusive.The device is not being returned and no photographic evidence was provided.Therefore, the reported failure cannot be verified, and root cause can not be identified.The service history was reviewed and no data was found.A review of the device history records (dhr) by the supplier determined that (b)(4) devices were manufactured and accepted into final stock in dec 2016 with no reported discrepancies.The device was never serviced by w.O.M.(manufacturer).(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user that higher insufflation pressures (>15mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Additional information was received from the reporter.Information indicates the procedure was a robot assisted laparoscopic distal gastrectomy.A suture was inserted in xiphoid process to retract the liver.In total, 5 ports were used.One port was inserted in navel, the other four ports were inserted on the horizontal line of the navel.The distances between the inserted ports were same and they were about 6cm.Pressure settings were at 10mmhg with the as-ifs unit.There were no issues noticed with the as-ifs unit, asm-evac1 tubing or 12-100lpi port prior to the issue.There was an x ray image taken during the surgery, however this intraoperative x ray image did not show pneumothorax.Two days after the surgery, spo2 dropped to 80%.Then another x ray image was taken and this postoperative x ray image showed pneumothorax.

• Brand Name: AIRSEAL IFS UNIT 110V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin, 10587 ; GM 10587
• MDR Report Key: 11557621
• MDR Text Key: 242172007
• Report Number: 1320894-2021-00133
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K143404
• 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: 04/12/2021

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: AS-IFS1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12-100LPI PORT, DETAILS UNKNOWN; ASM-EVAC1 TUBING , DETAILS UNKNOWN
• Patient Outcome(s): Other
• Patient Age: 84 YR