MAUDE Adverse Event Report: STRYKER ENDOSCOPY PUREVIEW; TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC

Catalog Number 0620-030-100

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2015

Event Type  malfunction  

Event Description

During a robotic procedure, the circulator stated the surgeon wasn't happy with the way the gas was being evacuated out of the patient so they took two of these smoke evac devices and hooked it up to two different trocars.During the use of this device the circulator went to change the gas tank and this device sucked out all the gas inside the patient, leaving the robotic instruments and light source to the scope on which could potentially harm the patient.As the stomach was deflated, there was a concern if the patient could have been burned due to inability to see inside the patient when stomach was deflated too quickly by the device.The representative of the company was notified about the use of this new product as there was not a proper in service on the use of the device.

• Brand Name: PUREVIEW
• Type of Device: TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical court; san jose CA 95138
• MDR Report Key: 4931214
• MDR Text Key: 6436953
• Report Number: 4931214
• Device Sequence Number: 1
• Product Code: NKC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/06/2015

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: Invalid Data
• Device Catalogue Number: 0620-030-100
• Device Lot Number: 15A31N
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR