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

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.

• Brand Name: BIOPSY FORCEPS
• Type of Device: CARDIOLOGY 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 Key: 5644207
• MDR Text Key: 46475290
• Report Number: 1016427-2016-00013
• Device Sequence Number: 1
• Product Code: DWZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K933235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 504302
• Device Lot Number: 70615261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1