MAUDE Adverse Event Report: INTEGRA YORK, PA INC. LARYNGEAL MIRROR W/HANDLE #4; N/A

Catalog Number 460105

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

On 10/05/2016 integra investigation completed.Ten mirrors returned, 4 manufactured in oct/nov 2015 and 6 manufactured in feb 2015.Method: failure analysis, device history evaluation.Results: failure analysis - mirrors returned used with no unusual markings and mirrors falling off of the frames.Upon further investigation, it is noticed that the adhesive that is used to affix the mirrors to the frames is melted and not holding the mirrors on the frames.Device history evaluation - nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: this is a known issue and appropriate action has been implemented to rectify this manufacturing deficiency.

Event Description

Customer initially reports mirrors are not staying glued together.On (b)(6) 2016 customer reports mirrors are falling off in patients mouth, but mainly after sterilization, no harm done.

• Brand Name: LARYNGEAL MIRROR W/HANDLE #4
• Type of Device: N/A
• 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: 6035279
• MDR Text Key: 57806614
• Report Number: 2523190-2016-00163
• Device Sequence Number: 1
• Product Code: KAI
• 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: Dental Assistant
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 460105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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