MAUDE Adverse Event Report: STRYKER PUERTO RICO, LTD. STRYKER'S LAPAROSCOPIC SMOKE EVA; INSUFFLATOR, LAPAROSCOPIC

Model Number PNEUMOCLEAR

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

Stryker's laparoscopic smoke evacuation, device did not work properly.Before stryker tech could come to the room to find out, the device was inoperative.We could have brought in another stryker tower and hooked up the stryker smoke evacuator to the current tubing, but the surgeon chose to open the trocar ports to release the co2 smoke from inside the patient's abdomen and into the operating room air supply.This exposed 5 other members of the surgical team to internal co2 plume unnecessarily.Fda safety report id# (b)(4).

• Brand Name: STRYKER'S LAPAROSCOPIC SMOKE EVA
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER PUERTO RICO, LTD.
• MDR Report Key: 10754934
• MDR Text Key: 213878691
• Report Number: MW5097515
• Device Sequence Number: 1
• Product Code: HIF
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PNEUMOCLEAR
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR