MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AIRSEAL IFS, 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

Additional fda product code: gcj.Manufacturer narrative: the device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.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 customer reported that the device, as-ifs1, was used during a robot-assisted distal gastrectomy on an unknown date.There was no report or claim that the device malfunctioned in any way; however, the reporter stated that after the procedure "respiratory function of the patient was not good.The x-ray image showed pneumothorax." the patient had prolonged hospitalization for 3-days while the condition was resolved using drainage.The current status of the patient has not been reported to conmed.This report is being raised on the basis of injury due to the report of patient condition of pneumothorax/prolonged hospitalization.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.A dhr review was not conducted as the device was in the field more than 12 months.The service history was reviewed, and no relationship to this complaint was found.A two-year review of complaint history revealed there has been a total of two complaints, regarding two devices, for this device family and failure mode.During this same time frame 1,848 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.001.Per the instructions for use, the user is advised that higher insufflation pressures (> 15 mm 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.

Manufacturer Narrative

Due to a reassessment of the two-year review of complaint history, the number of complaints has been recalculated from 2 to 36 and the number of complaint devices has been recalculated from 2 to 36.(b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL IFS, 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: 11379242
• MDR Text Key: 233538115
• Report Number: 1320894-2021-00090
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 60 YR