MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH PNEUMOCLEAR; CARBON DIOXIDE INSUFFLATOR FOR LAPAROSCOPY AND VESSEL HARVESTING

Model Number FM300

Device Problem Insufficient Information (3190)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

The event description is very poor and general.Preventive maintenance of the device has been over-due for more than 1 year.At the time of the reporting decision the device was returned 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).

Event Description

The pneumoclear co2 conditioning insufflator (#(b)(6)) malfunctioned while the pa-c (certified physician's assistant) was using it for endoscopic vein harvesting.Initially, the equip-ment showed that insufflation was active,' but the pa-c was struggling with the view of the vein on the monitor.Stryker was paged upon this discovery and then it began working on its own before they made it to the room.Approximately an hour later, the equipment was alarming that there was an occlusion.' writer paged stryker again and obtained new insufflation tubing and vasoview accessory kit, in the event that it was a part of the issue.Pa-c was unable to troubleshoot with the new supplies and stryker was unable to troubleshoot the equipment.A new pneumoclear co2 conditioning insufflator was brought to the room and set up by stryker.The new equipment worked; however, at this point the pa-c had to go open' in order to retrieve the vein from the patient's leg.Which thus caused four addition-al incisions in the patient's leg and a delay in the surgery.How was issue noticed?: during procedure.Procedure completed successfully?: yes.Patient involvement?: yes - impact.Medical intervention?: yes.Surgical delay?: yes - not reported.Adverse consequences?: patient.Adverse consequence details: had to go open' in order to retrieve the vein from the patient's leg.Which thus caused four additional incisions in the patient's leg and a delay in the surgery.Product available for return?: return.

• Brand Name: PNEUMOCLEAR
• Type of Device: CARBON DIOXIDE INSUFFLATOR FOR LAPAROSCOPY AND VESSEL HARVESTING
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrase 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: sushira panchama ; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• MDR Report Key: 19039870
• MDR Text Key: 339324684
• Report Number: 3002914049-2024-00002
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FM300
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other