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

Model Number 0620040690

Device Problem Connection Problem (2900)

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

Event Date 01/04/2022

Event Type  malfunction  

Event 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
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 13306598
• MDR Text Key: 284112755
• Report Number: 13306598
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 07613327055658
• UDI-Public: (01)07613327055658(11)210701(17)240701(10)21G0135
• 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: 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
• Device Operator: 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
• Date Report Sent to FDA: 01/06/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Female
• Patient Weight: 143 KG