MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH PNEUMOCLEAR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620050250

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 04/23/2021

Event Type  malfunction  

Event Description

The stryker pneumoclear smoke evacuation high-flow tube set was plugged into the stryker insufflator and an error message read "incorrect tube set".Writer attempted to activate insufflation at the start of the surgery without success.Writer attempted to disconnect and reconnect the tubing.A new tubing set was retrieved and plugged into the insufflator.The new tubing worked flawlessly.

• Brand Name: PNEUMOCLEAR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; 4531 36th st.; orlando FL 32811
• MDR Report Key: 11816916
• MDR Text Key: 250419925
• Report Number: 11816916
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0620050250
• Device Lot Number: 4020933
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Weight: 68