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

Model Number	FM300
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from subcutaneous emphysema resulting in the patient needing a chest tube and icu care.
Additional 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).
Additional 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 or Problem 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)
• Common Device Name: 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
• Report Number: 0002936485-2023-00293
• Device Sequence Number: 11174962
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: FM300
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown