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

Model Number	FM300
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
It was reported that the patient coded during procedure and was airlifted to another hospital.
Event or Problem Description
It was reported that the patient coded during procedure and was airlifted to another hospital.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: unknown issue with insufflator.Probable root cause: because device was not returned to oem - wom, probable root cause cannot be determined.A veress needle is used to create pneumoperitoneum for laparoscopic surgery.When the needle is placed in a peritoneal cavity, co2 passed from the insufflator through the tube set and the veress needle to fill the abdomen with gas and create a pneumoperitoneum.In the present case an issue with the insufflator was not observed.After further discussion with our distributor, stryker, who was in contact with the complainant, opined that the physician likely set the veress needle incorrectly and the patient then coded.The currently assumed most possible root cause might be incorrect positioning of the veress needle leading to air embolism.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.

• 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: 14453107
• Report Number: 0002936485-2022-00255
• Device Sequence Number: 20421841
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/27/2022

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: 04/19/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/27/2022
• 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