MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS); INSUFFLATOR, LAPAROSCOPIC

Model Number FM300

Device Problem Pressure Problem (3012)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 03/15/2023

Event Type  Injury  

Event Description

It was reported that the patient suffered from subcutaneous emphysema resulting in the patient needing a chest tube and icu care.

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.Filling on behalf of world of medicine (wom).

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: pressure issue.Expanded investigation activities.The device was investigated by stryker on-site with the following conclusion provided on march 31,2023.The device is overdue for its scheduled 2-year preventative maintenance; however, no error logs were present, and the pressure sensor is displaying correct values.The "exceed safety threshold" alert functioned correctly in all operating modes.The "exceed safety threshold" alert was displayed during the case with the alleged incident.Probable root cause: because device was not returned to oem - wom, probable root cause cannot be determined.The device was investigated by the distributor at the end users facility.The results of the functional inspection were as follows: the device is overdue for its scheduled 2-year preventative maintenance; however, no error logs were present, and the pressure sensor is displaying correct values.The "exceed safety threshold" message and signal functioned correctly in all operating modes.The "exceed safety threshold" message was displayed during the case with the alleged incident.No further action is indicated at this time.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

Event Description

It was reported that the patient suffered from subcutaneous emphysema resulting in the patient needing a chest tube and icu care.

• Brand Name: PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS)
• 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: 16718655
• MDR Text Key: 313104880
• Report Number: 0002936485-2023-00293
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

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 Model Number: FM300
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• 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