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	Airway Obstruction (1699)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.Filling on behalf of world of medicine (wom).
Event or Problem Description
It was reported that the patient was unable to be ventilated during the case.
Event or Problem Description
It was reported that the patient was unable to be ventilated during the case.
Additional Manufacturer Narrative
This device was received at oem-wom for evaluation.Based on the oem-wom investigation report , the reported failure ¿actual pressure will go up on its own¿ was not confirmed.According to wom: visual inspection.The device was received on apr 26, 2023 for evaluation.The device was shipped with the correct packaging, and no damage was found.The device is in poor overall condition, upper and lower housing were damaged due to an impact or drop, silicon tube port was detached from housing, and front panel was scratched.Functional inspection: functional inspection indicated the returned device passed all criteria.This included a pressure, flow and overpressure test with a result of pass.Dimensional inspection: due to the nature of the reported event, the dimensional inspection was deemed unnecessary and therefore not performed.Investigation conclusion: the results of the investigation performed indicated that the returned pneumoclear plus co2 conditioning insufflator, catalog #0620050000 rev ye, sn (b)(6) is working according to specification.Probable root cause: the most probable root cause is the use of a tight trocar/instrument combination which limits the equalization of pressure between cavity and tube set and consequently displays higher pressure values on the insufflator than the pressure in the cavity or poor patient relaxation.The reported failure mode will be monitored for future reoccurrence.Stryker is the initial importer of this product.The legal manufacturer is world of medicine (wom).Wom has been made aware of this report event.

• 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: 16943265
• Report Number: 0002936485-2023-00465
• Device Sequence Number: 7012935
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K201361
• 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): 08/04/2023

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: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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