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 Problems Air Embolism (1697); Embolism/Embolus (4438)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

Additional product code: gcj.The reported event of ¿when the cover cloth was removed, the patient developed scrotal emphysema¿ 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 was reviewed, and no data was found.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.A two-year review of complaint history revealed there has been a total of 8 reports, regarding 8 devices, for this device family and failure mode.(b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Conmed (b)(6) reported on behalf of their customer that the device, as-ifs1, airseal ifs, 110v was being used on (b)(6) 2022 during a robotically-assisted laparoscopic rectal cancer procedure when it was reported ¿after the operation, when the cover cloth was removed, it was confirmed that the patient developed scrotal emphysema.The patient was in remission a few days later.The procedure was completed and there was no delay.Further assessment found ¿the gas settings were smoke exhaust : low.Initial insufflation 20l.Insufflation at 5l at the beginning of camera port placement.After it is confirmed that it is in, increase to 20l.¿ medically pure co2 was used.The patient doesn¿t have co-morbidities; however, bmi is in the ¿low 20s, below 30¿.No medical treatment was needed, the patient had "spontaneous recovery" and is currently in remission after a few days.This report is being raised on the basis of injury due to scrotal emphysema.

• 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: 14053302
• MDR Text Key: 288886361
• Report Number: 1320894-2022-00073
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic