MAUDE Adverse Event Report: INTERSURGICAL INCORPORATED INTERSURGICAL; DUAL HEATED WIRE BREATHING SYSTEM WITH AUTO FILL CHAMBER

Catalog Number 2026031

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Type  No Answer Provided  

Event Description

It is reported that the temperature probe pops out of temperature port at water chamber.Reported item was not being used on a patient.

• Brand Name: INTERSURGICAL
• Type of Device: DUAL HEATED WIRE BREATHING SYSTEM WITH AUTO FILL CHAMBER
• Manufacturer (Section D): INTERSURGICAL INCORPORATED; 6757 kinne street; east syracuse NY 13057
• Manufacturer Contact: ivan seniut ; arnioniu, 60/28-1; lt-18170; pabrade, ; LH ; 38766609
• MDR Report Key: 5587867
• MDR Text Key: 44162752
• Report Number: 1319447-2016-70011
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2016,04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2026031
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/01/2016
• Date Report to Manufacturer: 03/02/2016
• Date Manufacturer Received: 03/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other