MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1); INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620040611

Device Problems Increase in Pressure (1491); Use of Device Problem (1670)

Patient Problems Myocardial Infarction (1969); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  Injury  

Event Description

It was reported that the patient suffered a heart attack.The patient is now well.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the patient suffered a heart attack.The patient is now well.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: serious injury due to patient experiencing a heart attack.Probable root cause: 1.Pressure sensor malfunction / out of calibration.2.Software malfunction.3.Use error: 4.System design.5.Unwanted movement of internal components / wiring.6.Pressure button does not disengage.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18375065
• MDR Text Key: 331124725
• Report Number: 0002936485-2023-01310
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0620040611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other