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	03/31/2023
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 suffered negative impact to their vitals.
Additional Manufacturer Narrative
This device was received at oem-wom for evaluation.Based on the oem-wom investigation report , the reported failure ¿over pressure¿ was not confirmed.According to wom: visual inspection.The device was received on apr 18, 2023 for evaluation.The unit was shipped with the correct packaging, (packaging in good condition) device in fair cosmetic condition, device presented some damage on lower and upper casing.Functional inspection: functional inspection indicated the returned device passed all criteria.This included a pressure, occlusion, safety valve 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 v, sn (b)(6) is working according to specification.Probable root cause: the complainant stated that during a pediatric surgery, the patient's vitals went down and when insufflation stopped patient's vitals went back to normal.It was confirmed that the user used the advanced mode and not the pediatric mode as intended.The advanced flow operating mode is designed for laparoscopies performed on normal weight and obese patients over the age of 14.The advanced flow operating mode is not designed for newborns, infants, and children under the age of 14.The pediatric operating mode is designed for these patient groups.Therefore, the most probable root cause is an off-label use 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.Please note that section g4 has been updated to k201361.
Event or Problem Description
It was reported that the patient suffered negative impact to their vitals.

• 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: 16820287
• Report Number: 0002936485-2023-00347
• Device Sequence Number: 12545769
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 02/19/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• 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