MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-01-16 for COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS FBFE-5.2-120 manufactured by Cook Inc.
[97346375]
Common name = device, biopsy, endomyocardial; (b)(4). (b)(4). This report includes information known at this time.? A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[97346376]
It was reported that during a biopsy, the cook flexible myocardial biopsy forceps did not close properly. Myocardial tissue was unable to be captured as a result. As no other forceps were available, the procedure was unable to be completed and was cancelled. Additional information regarding how the procedure was completed, event details, and patient outcome has been requested, but is not available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00149 |
| MDR Report Key | 7194416 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-01-16 |
| Date of Report | 2018-02-01 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2018-01-31 |
| Device Manufacturer Date | 2016-11-08 |
| Date Added to Maude | 2018-01-16 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS |
| Product Code | DWZ |
| Date Received | 2018-01-16 |
| Catalog Number | FBFE-5.2-120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-16 |