MAUDE Adverse Event Report: INTEGRA YORK, PA INC. DIA DETACH KERRISON MEDIUM 40UP 8; RUGGLES-REDMOND

Catalog Number RD4822DTM

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

On 9/21/16 integra investigation completed.Method: failure analysis, devise history evaluation results: failure analysis - failure analysis cannot be performed based on the lack of information provided by the customer.The rongeurs were not returned for further evaluation.Devise 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/corrections: none.Health hazard evaluation history: none.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.The rongeurs were not returned for further evaluation.

Event Description

Doctors are complaining that they are not sharp, they are not cutting, they are tearing.

• Brand Name: DIA DETACH KERRISON MEDIUM 40UP 8
• Type of Device: RUGGLES-REDMOND
• 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: 6028412
• MDR Text Key: 57447650
• Report Number: 2523190-2016-00171
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: K150428
• 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: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RD4822DTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• 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