• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION BIOPSY FORCEPS CARDIOLOGY WIRES & METALS (DWZ)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CORPORATION BIOPSY FORCEPS CARDIOLOGY WIRES & METALS (DWZ) Back to Search Results
Catalog Number 504302
Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/25/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(6). The product was returned for evaluation and testing; however, the engineering evaluation is not complete. Additional information will be submitted within 30 days upon receipt.
 
Event Description
As reported, during preparation, the tip/jaws of the 50 cm. 5. 5 fr. Biopsy forceps std was noted to be covered by something (like vinyl) and it was difficult to remove. The product was not clinically used in a patient. There was no reported patient injury. The product will be returned for inspection. Additional information received indicated that it was not known if the vinyl like covering (reported product issue) was a foreign substance or was if it was possibly a piece of the packaging of the device/complaint product-pending inspection of the returned product. A picture of the reported product issue was received and is attached. There was no reported difficulty removing the product from the packaging. Another biopsy forcep was used to complete the procedure successfully. The product was stored properly according to the instructions for use (ifu). There was no damage noted to the product packaging upon inspection prior to opening. There was no reported difficulty removing the product from the packaging. The product was inspected prior to use and appeared to be normal. The product was prepped properly according to the instructions for use (ifu) with no problems noted. No additional information is available. Addendum: based on the preliminary analysis received and after clinical input, the subject code of packaging/pouch/box-removal difficulty is being removed and the subject code of packaging/pouch/box-foreign material is being added.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIOPSY FORCEPS
Type of DeviceCARDIOLOGY WIRES & METALS (DWZ)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
14201 nw 60th avenue
miami lakes, FL 33014
7863133880
MDR Report Key5644207
MDR Text Key46475290
Report Number1016427-2016-00013
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
Type of Report Initial
Report Date 12/28/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2018
Device Catalogue Number504302
Device Lot Number70615261
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-