MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-10 for BIOPSY FORCEPS 504302 manufactured by Cordis Corporation.
[46475290]
(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.
Patient Sequence No: 1, Text Type: N, H10
[46475291]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1016427-2016-00013 |
| MDR Report Key | 5644207 |
| Date Received | 2016-05-10 |
| Date of Report | 2015-12-28 |
| Date of Event | 2015-12-25 |
| Date Mfgr Received | 2016-05-04 |
| Device Manufacturer Date | 2015-08-21 |
| Date Added to Maude | 2016-05-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CECIL NAVAJAS |
| Manufacturer Street | 14201 NW 60TH AVENUE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863133880 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOPSY FORCEPS |
| Generic Name | CARDIOLOGY WIRES & METALS (DWZ) |
| Product Code | DWZ |
| Date Received | 2016-05-10 |
| Returned To Mfg | 2016-04-04 |
| Model Number | NA |
| Catalog Number | 504302 |
| Lot Number | 70615261 |
| Device Expiration Date | 2018-05-31 |
| 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 NW 60TH AVENUE MIAMI LAKES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-10 |