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

Model Number	FM300
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
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 (b)(6).
Event or Problem Description
It was reported the procedure was converted to open surgery.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: flow was not adequate during vessel harvest had to convert to open to harvest the vessel probable root cause: because device was not returned to oem - wom, probable root cause cannot be determined.The reported event could be not confirmed.There are no indications of a manufacturing issue.The most probable root cause is, that (a) the blue so called one-way valve of co2 lnsufflation port on the vasoview hemopro 2-device is too short or misplaced, so the luer lock cone could not press the one-way valve to open or (b) the luer lock was not properly tightened to open the one-way valve on the co2 distal insufflation port on the vasoview hemopro 2- device.Expanded investigation activities not possible because the device was not returned for evaluation.However, tests on w.O.M.-r&d, which had been proceeded with pneumoclear-lnsufflator, pneumoclear tube set and a vasoview hemopro 2-device, concluded the following: ¿ the maximum flow is about seven liters per minute at an adjusted flowrate of ten liters per minute ¿ the main reason for this limitation is due to the very thin hoses of the vasoview hemopro 2-device (id approx.2mm) ¿ if the tube set will be correctly tightened, then the cone of the luer lock will move the blue valve stick at the co2 distal insufflation port about 1.5mm ¿ at approx.0.5mm movement of the blue valve stick, the valve will be opened sufficiently to reach the above-mentioned flow rates ¿ it was not possible to generate a scenario that the tube is tightened and there is no flow the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported the the procedure was converted to open surgery.

• 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: 12506303
• Report Number: 0002936485-2021-00508
• Device Sequence Number: 19182985
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/08/2021

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: 08/24/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/08/2021
• 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