MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for BIOPSY FORCEPS 5.5F STD 104CM 504300 manufactured by Cordis Corporation.
[125127961]
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.
Patient Sequence No: 1, Text Type: N, H10
[125127962]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1016427-2018-01906 |
| MDR Report Key | 7938033 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-07-27 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2018-10-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KARLA CASTRO |
| Manufacturer Street | 14201 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863138372 |
| Manufacturer G1 | CORDIS CORPORATION |
| Manufacturer Street | 14201 NORTH WEST 60TH AVENUE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOPSY FORCEPS 5.5F STD 104CM |
| Generic Name | DEVICE, BIOPSY, ENDOMYOCARDIAL |
| Product Code | DWZ |
| Date Received | 2018-10-05 |
| Returned To Mfg | 2018-09-04 |
| Catalog Number | 504300 |
| Lot Number | 70817261 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | 14201 NORTH WEST 60TH AVENUE MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-05 |