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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION BIOPSY FORCEPS 5.5F STD 104CM DEVICE, BIOPSY, ENDOMYOCARDIAL

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CORDIS CORPORATION BIOPSY FORCEPS 5.5F STD 104CM DEVICE, BIOPSY, ENDOMYOCARDIAL Back to Search Results
Catalog Number 504300
Device Problem Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/27/2018
Event Type  malfunction  
Manufacturer Narrative
Prior to use, when opening a box of 104cm 5. 5f biopsy forceps it was noted that there was no sterilized inner packaging, there was only a product. The device was stored and handled per the instructions for use (ifu). The actual product was not damaged. No other information was reported. One unit of non-sterile 104 cm 5. 5f biopsy forceps was received for analysis inside a plastic bag without its original packaging. Per visual analysis, there were sweeping bends observed in the jacket. Per functional analysis, despite the bends, when the device was actuated, the jaws did open and close as designed. Per microscopic analysis, the jaws were examined under 10x magnification and no anomalies were noted. A product history record (phr) review of lot 70817261 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The phr review does not suggest that the event reported by the customer could be related to the manufacturing process. Therefore, no root cause investigation was required since no defects were related to the manufacturing or assembly identified during the device evaluation. The event reported as ¿packaging/pouch/box-compromised sterility¿ was not confirmed since no original packaging was returned for analysis. The device was returned for analysis inside a plastic bag. The device was evaluated and functioned as designed. The cause of the event reported could not be conclusively determined during the analysis. Per to the instructions for use, which is not intended as a mitigation, ¿do not use if the inner package is open or damaged. ¿ neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit. Therefore, no corrective or preventive actions will be taken.
 
Event Description
As reported, when the box of 104cm 5. 5f biopsy forceps was opened, there was no sterilized inner packing, there was only a product. The damage was noted when the product was opened. The device was stored and handled per the instructions for use (ifu). The actual product was not damaged.
 
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Brand NameBIOPSY FORCEPS 5.5F STD 104CM
Type of DeviceDEVICE, BIOPSY, ENDOMYOCARDIAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 north west 60th avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 north west 60th avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key7938033
MDR Text Key125127961
Report Number1016427-2018-01906
Device Sequence Number1
Product Code DWZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K933235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number504300
Device Lot Number70817261
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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