MAUDE Adverse Event Report: KARL STORZ SE & CO KG STORZ INSUFFLATOR ENDOFFLATOR 50 MODEL IU 500; INSUFFLATOR, LAPAROSCOPIC

Model Number IU 500

Patient Problems Cardiac Arrest (1762); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/16/2023

Event Type  Death  

Event Description

Upon initiation of insufflation during a laparoscopic procedure the patient experienced immediate decline in hemodynamic status, followed by a cardiac arrest.Upon return of spontaneous circulation after cpr a ct(cardiopulmonary resuscitation a computed tomography) of the chest showed a massive amount of air within heart, pulmonary and systemic circulation.The patient expired later on the same day.

• Brand Name: STORZ INSUFFLATOR ENDOFFLATOR 50 MODEL IU 500
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): KARL STORZ SE & CO KG
• MDR Report Key: 18204813
• MDR Text Key: 328991609
• Report Number: MW5148444
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IU 500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White