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

The exact date of the surgery is unknown.On (b)(6) 2021, it was reported to the conmed representative as " roughly two weeks ago" hence on or about (b)(6) 2021.Additional product code; gcj.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

On behalf of the customer, the conmed representative reported an incident that occurred at (b)(6) medical center, on or about (b)(6) 2021.The conmed representative was told on (b)(6) 2021 by the surgeon that the incident happened 2 weeks prior.It was reported that during a periesophageal hernia case his patient had a pneumothorax & required a chest tube.It was reported there was an airseal unit and airseal "disposable" devices used in the procedure.The surgeon had indicated there was no allegation of defect or fault with the conmed equipment.It was confirmed the chest tube was in for one day and the patient was sent home and has since recovered.It was reported the procedure was going well but the surgeon was dealing with a large hernia at the top of abdominal cavity encroaching into the chest cavity.The surgeon was trying to move the hernia down and back into the abdominal cavity and was pushing on the patient's diaphragm & chest cavity.The patient began to have difficulty breathing and it was determined a pneumothorax (collapsed lung) had occurred.A chest tube was inserted.The procedure was successfully completed with no further complications or issues.The surgeon mentioned that pneumothorax was a well-known complication of this surgical procedure, especially when involving older or large (bariatric) patients.He wanted to ask about possible pro-active precautions that could be taken for the future.The surgeon was put in touch with conmed's vp of clinical affairs for further discussion.The surgeon again confirmed there was no fault with the conmed devices and/or equipment.No other information or device specifics was provided.Although there is no allegation of defect or fault with the airseal unit or associated devices, this mdr reporting is being raised on the basis of injury for the mention of pneumothorax, requiring a chest tube.

Manufacturer Narrative

Investigation of the customer's reported issue and complaint was is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.The service history could not be reviewed as a serial number was not provided.As a serial number was not provided, conmed could not request and conduct a review of the manufacturing documents from vendor.A two-year review of complaint history for similar failure modes revealed there has been a total of 40 complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure (b)(4).As this is a reusable device, the potential number of uses is not considered in this occurrence rate.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu advises the user 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.

• 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: 11634667
• MDR Text Key: 244939087
• Report Number: 1320894-2021-00187
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• 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: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AIRSEAL LP PORT, SIZE UNKNOWN; ASM-EVAC1 TUBING, UNKNOWN DETAILS
• Patient Outcome(s): Required Intervention