MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-01 for JAWZ EMB FORCEPS 190081 manufactured by Argon Medical Devices Inc..
[85371429]
A review of the device history records and inspection records was conducted and no similar concerns were found. No samples or photos were returned, so the issue could not be confirmed. Since the sample is not available for return and there were no concerns noted in the manufacturing documentation, no further evaluation can be conducted at this time.
Patient Sequence No: 1, Text Type: N, H10
[85371430]
The insulation right behind the tip came free when the user pulled back on the handle. Of course, this happen while in the heart. The user thinks the spring was caught on the tricuspid valve. It took about five minutes of manipulating and the user was finally able to free it without ripping the valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2017-00121 |
| MDR Report Key | 6840486 |
| Date Received | 2017-09-01 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-08-03 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-09-01 |
| 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 | MS. GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK ROAD |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 2144368995 |
| Manufacturer G1 | ARGON MEDICAL DEVICES INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JAWZ EMB FORCEPS |
| Generic Name | ENDOMYOCARDIAL BIOPSY FORCEPS |
| Product Code | DWZ |
| Date Received | 2017-09-01 |
| Catalog Number | 190081 |
| Lot Number | G38301 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-01 |