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 Airway Obstruction (1699)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.Filling on behalf of world of medicine (wom).

Event Description

It was reported that the patient was unable to be ventilated during the case.

Event Description

It was reported that the patient was unable to be ventilated during the case.

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)
• 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: 16943265
• MDR Text Key: 315352036
• Report Number: 0002936485-2023-00465
• 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: K201361
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• 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