MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH STRYKER PNEUMOCLEAR SMOKE EVACUATION HIGH FLOW TUBING SET INSUFFLATION TUBING; INSUFFLATOR, LAPAROSCOPIC

Model Number 0620050250

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Stryker pneumoclear smoke evacuation tubing set ref (b)(4) has particulates of activated charcoal inside the packaging.Is this safe to go into the abdomen? does the fda approve of this particulate in the product packaging? fda safety report id# (b)(4).

• Brand Name: STRYKER PNEUMOCLEAR SMOKE EVACUATION HIGH FLOW TUBING SET INSUFFLATION TUBING
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH
• MDR Report Key: 15537116
• MDR Text Key: 301182384
• Report Number: MW5112399
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0620050250
• Device Lot Number: 4025961
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other