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

Model Number	0620040690
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Adult female with history of obesity and persistent atrial fibrillation.Procedure: hybrid convergent maze procedure with posterior left atrial wall ablation, left atrial appendage exclusion with atriclip.Issue: stryker co2 high flow tubing would not connect to the stryker tower.New tubing obtained and worked appropriately.

• Brand Name: PNEUMOSURE
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 13306598
• Report Number: 13306598
• Device Sequence Number: 3346378
• Product Code: HIF
• UDI-Device Identifier: 07613327055658
• UDI-Public: (01)07613327055658(11)210701(17)240701(10)21G0135
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/06/2022
• Report Date (Section F): 01/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: 0620040690
• Device Catalogue Number: 0620-040-690
• Device Lot Number: 21G0135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 143 KG
• Date Report Sent to FDA: 01/06/2022