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

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.

• Brand Name: BIOPSY FORCEPS 5.5F STD 104CM
• Type of Device: DEVICE, 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 Key: 7938033
• MDR Text Key: 125127961
• Report Number: 1016427-2018-01906
• 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: 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

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 504300
• Device Lot Number: 70817261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1