MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CARB EDGE IRIS SCS 4-1/2 CVD; N/A

Catalog Number 101-301

Device Problem Break (1069)

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

A set of iris scissors used for transphenoidal surgery broke inside of nose with little to no pressure being applied.All pieces removed in 2 parts.Caused little delay to case and no notable trauma to patient.

Manufacturer Narrative

2/2/2016 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation.Results: failure analysis - scissors were returned in used condition, not showing any unusual markings.The returned scissors showing excessive wear, blackish/dark brown staining, repair markings and a broken tip.While visually inspecting the scissors, it is noticed that there is dark brown/black staining.This is the result from detergents used to clean the instrument.The black acid staining can be caused by low ph (less than six) during autoclaving.It is also noticed that the tip is broken.It appears the damage to the tip may have been due to the corrosion weakening the instrument.This type of damage is typically the result of improper processing.The complaint is confirmed; damage/ worn.Device history evaluation - dhr review was completed with all history available.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: the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: CARB EDGE IRIS SCS 4-1/2 CVD
• 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: 5407994
• MDR Text Key: 37437019
• Report Number: 2523190-2016-00009
• Device Sequence Number: 0
• Product Code: HNF
• 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,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101-301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2016
• 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
• Patient Age: 39 YR