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 Stroke/CVA (1770)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

Additional fda product code: gcj.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 conducted by the vendor indicates (b)(4) devices were manufactured under the same work order and accepted into final stock in aug 2019 with no reported discrepancies.The service history was reviewed, and no data was found.(b)(4).Per the instructions for use, the user is advised that insufflation of co2 should be done carefully and while monitoring the patient's response.The user, particularly the anesthetist, should be informed about possible cardiovascular and respiratory problems of the patient and monitor these intra-operatively.The ifu also warns the user that insufflating co2 may result in metabolic acidosis.This can lead to cardiac irregularities expressed with the following symptoms: reduced aspiration with restricted diaphragm functions, hypercapnia and reduced cardiac output.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 being used during laparoscopic partial liver resection on (b)(6) 2021 when it was reported "after the surgery, the patient had stroke." the procedure had been completed when the stroke occurred.There was no report of device malfunction; only that the device had been used during the procedure.There was no report of any type of delay during the procedure and no report of an alternate device being used during the procedure.Further assessment questions were asked of the reporter; however, to date there has been no response.This report is being raised on the basis of injury due to patient having stroke after procedure.

• 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
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin 10587 ; GM 10587
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 11777172
• MDR Text Key: 249089899
• Report Number: 1320894-2021-00210
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2021

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: 04/16/2021
• Initial Date FDA Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other