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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RUGGLES FUKUSHIMA RETRACTION SYSTEM WITH STERILI N/A

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INTEGRA YORK, PA INC. RUGGLES FUKUSHIMA RETRACTION SYSTEM WITH STERILI N/A Back to Search Results
Catalog Number R9100
Device Problem Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
On 3/24/2017 integra investigation completed: method: failure analysis, device history evaluation. Results: failure analysis - failure analysis cannot be performed based on the lack of information provided by the customer. No device returned for further evaluation. 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/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. Instrument was not returned.
 
Event Description
Customer reports the first time this new fukushima retractor was used doctor was disappointed that the retractor arms did not stay in position ¿ did not hold as much tension as he expected. No specific case/patient data available. No injury or delay to report.
 
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Brand NameRUGGLES FUKUSHIMA RETRACTION SYSTEM WITH STERILI
Type of DeviceN/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 Key6475450
MDR Text Key72522506
Report Number2523190-2017-00043
Device Sequence Number1
Product Code HBG
Combination Product (y/n)N
PMA/PMN Number
K902818
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 03/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberR9100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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