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

Catalog Number AS-IFS1

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 07/26/2023

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the as-ifs1, airseal ifs, 110v was being used on (b)(6) 23 and ¿during surgery gas was low on 1 tank after switched tanks no gas came out.Per transplant coordinator they do not think the gas was turned on by staff.Doctor said surgery caused pneumothorax, patient ok per doctor.¿.This report is being raised on the basis of injury due to device with no report of malfunction being used during a procedure where the patient experienced pneumothorax.

Manufacturer Narrative

The reported device has been returned to conmed; however, the evaluation of the device has not been completed.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Manufacturer Narrative

Reported event of ¿pneumothorax¿ was not confirmed during the evaluation process.Performed annual inspection, calibration, safety tests and placed unit on a 12-hour burn-in test.The unit completed and passed the 12-hour burn-in test.Upgraded the software to 2.2.1.0.The unit was tested per ip-800-031.The unit functions as per the specification.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed and no relationship to this complaint was found.(b)(4).Per the instructions for use, the user is advised the following: read the instructions for use carefully and become familiar with the operation and function of the device and the accessories before use during surgical procedures.Non-observance of the instructions listed in this manual can lead to life-threatening injuries of the patient, to severe injuries of the surgical team, nursing staff or service personnel, or to damage or malfunction of device and/or accessories.The default gas settings are selected at the factory and should be changed as necessary by the user.If a gas supply of greater than 15 bars/218 psi is supplied to the device, regardless if the default setting is set to bottle gas or house gas, the device will automatically default to bottle gas mode.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the as-ifs1, airseal ifs, 110v was being used on (b)(6) 2023 and ¿during surgery gas was low on 1 tank after switched tanks no gas came out.Per transplant coordinator they do not think the gas was turned on by staff.Doctor said surgery caused pneumothorax, patient ok per doctor.¿.This report is being raised on the basis of injury due to device with no report of malfunction being used during a procedure where the patient experienced pneumothorax.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer Contact: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 17606032
• MDR Text Key: 321770426
• Report Number: 1320894-2023-00163
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: 011085188500458711220623
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic