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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 INFLW/OUTFLW FORK SUCTN (3) ARTHROSCOPE

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SMITH & NEPHEW, INC. DYONICS 25 INFLW/OUTFLW FORK SUCTN (3) ARTHROSCOPE Back to Search Results
Catalog Number 7211004
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/06/2018
Event Type  malfunction  
Event Description
It was reported that a black substance was confirmed inside the patient through the arthroscope. The surgeon suspected that it was came out from a fluid tube line. They checked the tube and found the substance at the spike. It seems that the spike was molded with the substance, this means that it couldn¿t remove from the spike. No patient injuries or complications were reported.
 
Manufacturer Narrative
The device was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection of the bag spike and the customer provided pictures found black debris embedded in the plastic mold. The complaint was confirmed. The bag spike was sent to a lab for material analysis via infrared spectroscopy. The study was performed focusing only on the black debris in the component. The results of the analysis showed that the black debris is the same material as the bag spike and is within specification.
 
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Brand NameDYONICS 25 INFLW/OUTFLW FORK SUCTN (3)
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin 78735
MDR Report Key7322157
MDR Text Key101965566
Report Number1643264-2018-00202
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K051326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7211004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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