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

Model Number 0620050250

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2022

Event Type  malfunction  

Event Description

We were made aware of a sterility issue by the stryker representative about contamination in the packaging of the pneumoclear smoke evaluation high flow tube set (stryker--insufflation tubing).Current compromised lot numbers include: 4025383 (this is the most common lot number by far), 4024006, k21n334, k22a009, 4023461, 4023621, k21h210, k21k234, 4020970.

• Brand Name: PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; 4531 36th street; orlando FL 32811
• MDR Report Key: 14711672
• MDR Text Key: 294129554
• Report Number: 14711672
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0620050250
• Device Lot Number: 4025383
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1