MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ELEVATOR 3714383 GORNEY SUCTION 3MM TIP; PFM11

Catalog Number 3714383

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports surgeon using instrument during procedure, it broke at handle, tubing junction.On (b)(6) /2015 customer reports surgeon was performing a balloon sinuplasty to decrease size of the turbinates.Instrument broke in half and scratched the patients lip, no other harm done, no treatment necessary.

• Brand Name: ELEVATOR 3714383 GORNEY SUCTION 3MM TIP
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5212039
• MDR Text Key: 30836921
• Report Number: 2523190-2015-00113
• Device Sequence Number: 1
• Product Code: KAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3714383
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1