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

Model Number	FM300
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient experienced a subcutaneous emphysema.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: pressure issue.Probable root cause: because device was not returned to oem - wom, probable root cause cannot be determined.Most of the reasons for occurrence of a subcutaneous emphysema are related to surgical technique and trocar placement.Incorrect placement of a cannula, veress needle or a trocar into subcutaneous tissue may lead to emphysema, which can lead to crepitus.A big leakage of co2 around trocar incisions may also lead to subcutaneous emphysema.Other risk factors are prolonged surgeries, the use of many access points to the abdominal cavity and an elevated abdominal pressure.In addition, the event description does not include any indication for a device malfunction, nor is subcutaneous emphysema considered a serious injury.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the patient experienced a subcutaneous emphysema.

• Brand Name: PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (GLOBAL)
• 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: 16162181
• Report Number: 0002936485-2023-00024
• Device Sequence Number: 19475699
• Product Code: HIF
• UDI-Device Identifier: 04056702003456
• UDI-Public: 04056702003456
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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: 0620050010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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