MAUDE Adverse Event Report: STRYKER ENDOSCOPY; INSUFFLATOR, LAPAROSCOPIC

Model Number FM300

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

The pneumoclear co2 conditioning insufflator (b)(4) malfunctioned while the pa-c (certified physician¿s assistant) was using it for endoscopic vein harvesting.Initially, the equipment showed that ¿insufflation was active,¿ but the pa-c was struggling with the view of the vein on the monitor.Stryker was paged upon this discovery and then it began working on its own before they made it to the room.Approximately an hour later, the equipment was alarming that there was an ¿occlusion.¿ writer paged stryker again and obtained new insufflation tubing and vasoview accessory kit, in the event that it was a part of the issue.Pa-c was unable to troubleshoot with the new supplies and stryker was unable to troubleshoot the equipment.A new pneumoclear co2 conditioning insufflator was brought to the room and set up by stryker.The new equipment worked; however, at this point the pa-c had to ¿go open¿ in order to retrieve the vein from the patient¿s leg.Which thus caused four additional incisions in the patient¿s leg and a delay in the surgery.

• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct; san jose CA 95138
• MDR Report Key: 18836045
• MDR Text Key: 336868857
• Report Number: 18836045
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM300
• Device Catalogue Number: FM300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female