MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-17 for JAWZ EMB FORCEPS 190051 manufactured by Argon Medical Devices Inc..
[75432111]
A review of the package device history record and inspection records was conducted and no similar concerns were found. The returned device was evaluated and the issue was confirmed since the biopsy jaws do not open. This product is purchased fully packaged from a supplier. A supplier corrective action request has been sent to the supplier. A follow-up report will be submitted when the supplier provides their evaluation and conclusions.
Patient Sequence No: 1, Text Type: N, H10
[75432112]
Patient admitted for cardiac biopsy to rule out amyloidosis. Upon attempt to retrieve tissue sample the endomyocardial biopsy forcep became stuck in the superior vena cava (svc) right atrial junction and failed to open or release despite multiple attempts to open up. Patient was subsequently admitted emergently to the operating room where a sternotomy and small venotomy was completed to remove the biopsy forcep.
Patient Sequence No: 1, Text Type: D, B5
[96167908]
A review of the device batch record was performed for (b)(4), in-process and finished goods and there were no non-conformances or capas opened in relation to the nature of the complaint. All devices met all (b)(4), in-process and finished goods specifications upon release of the product. The returned device was evaluated by the supplier. Per the supplier,? The device was returned with the introducer still attached. The introducer was removed and the device was laid across the work bench. There were several severe bends in the outer jacket caused by over-actuation. The forceps would not open. The distal end of device was inspected under 10x magnification and it was clear that there was dried fluid preventing the jaws from opening. The jaws were soaked in hydrogen peroxide and the dried fluids were removed with a razor blade. Once a significant amount of dried fluid was removed, the jaws were able to open and close when actuated. These devices are functionally tested 100% prior to packaging. There is no root cause investigation at this time. Once the device was cleaned with hydrogen peroxide the jaws were able to open and close as intended even with the bends in the outer jacket.?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625425-2017-00072 |
| MDR Report Key | 6573438 |
| Date Received | 2017-05-17 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-03-31 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2016-12-30 |
| Date Added to Maude | 2017-05-17 |
| 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 | 3 |
| Brand Name | JAWZ EMB FORCEPS |
| Generic Name | ENDOMYOCARDIAL BIOPSY FORCEPS |
| Product Code | DWZ |
| Date Received | 2017-05-17 |
| Returned To Mfg | 2017-04-26 |
| Catalog Number | 190051 |
| Lot Number | G14888 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other; 2. Required No Informationntervention | 2017-05-17 |