MAUDE Adverse Event Report: STRYKER CORPORATION PNEUMOSURE; INSUFFLATOR, LAPAROSCOPIC

Model Number 620-040-650

Device Problem Device Alarm System (1012)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 01/17/2022

Event Type  malfunction  

Event Description

The manufacturer specific tubing has a built in adapter present.If that product is not seated properly, a notification on the insufflation machine will indicate ¿tube set not connected¿.The insufflation machine does have an adapter that allows for 3rd party insufflation tubing to be used.This adapter if not seated properly does not appear to trigger the ¿tube set not connected¿ alarm.Since this is the case, an improper seal may occur and the insufflation machine has the potential to insufflate to higher than desired pressure.Patient experienced respiratory issues and procedure was aborted.

• Brand Name: PNEUMOSURE
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical court; san jose CA 95138
• MDR Report Key: 13677692
• MDR Text Key: 286647087
• Report Number: 13677692
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 620-040-650
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20075 DA
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Race: White