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

Catalog Number	0620050000
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Unintended Loss of Vascular Access (4867)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was converted to open surgery and additional incisions to the patient's leg.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.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.
Additional Manufacturer Narrative
This device was received at oem-wom for evaluation.Based on the oem-wom investigation report, the reported failure ¿malfunctioned while was using it for endoscopic vein harvesting.¿ was not confirmed.According to wom: visual inspection the device was received on mar 12, 2024 for evaluation.There are no indications of transport damage or misuse.The device was shipped with the correct packaging (packaging arrived undamaged).The unit is in good overall condition, minor scratches found on the upper and lower casings.Functional inspection: initial self-check passed; no errors occurred.Functional testing was performed, and all tests were found to be within tolerance.No random occlusion alarms triggered during our testing.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 yb, sn (b)(6) is working according to specification.Probable root cause: the event description is very poor and general.Preventive maintenance of the device has been overdue for more than 1 year.At the time of the reporting decision the device was re-turned for evaluation and the evaluation results found to be within tolerance.No random occlusion alarms triggered during our testing.Complaint was not confirmed.However, we cannot exclude an user error/handling issue with the tube set and vessel harvesting instrument vasoview and the respective insufflation port so that the connection was not secured tightly and consequently the check valve was not opened correctly to allow the gas (co2) to pass.Nonetheless, the event description includes a defined risk to patient's health and led conversion to open surgery (open procedure).The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the procedure was converted to open surgery and additional incisions to the patient's leg.

• 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: 19028975
• Report Number: 0002936485-2024-00280
• Device Sequence Number: 6992572
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K201361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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 Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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 Age: 79 YR
• Patient Sex: Female