MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-24 for BPS300 BIPOLAR GRASPER manufactured by Grace Manufacturing Inc..
[107084853]
A sliver of black coating was found in the patient while using the bipolar. The sliver was taken out. Surgeon continued to use the bipolar afterwards. After the bipolar was taken out, the grasper on the bipolar appeared to have a missing part of the coating (same shape as the sliver). Overall, the surgeon was happy with this unit. No complications to the patient. Customer does not stock this item.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002770040-2018-12347 |
| MDR Report Key | 7455973 |
| Date Received | 2018-04-24 |
| Date of Report | 2018-04-24 |
| Date Mfgr Received | 2018-02-26 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2018-04-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRANDY DIXON |
| Manufacturer Street | 614 SR 247 |
| Manufacturer City | RUSSELLVILLE AR 72802 |
| Manufacturer Country | US |
| Manufacturer Postal | 72802 |
| Manufacturer Phone | 4799685455 |
| Manufacturer G1 | GRACE MANUFACTURING INC. |
| Manufacturer Street | 614 SR 247 |
| Manufacturer City | RUSSELLVILLE AR 72802 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72802 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BPS300 BIPOLAR GRASPER |
| Generic Name | BIPOLAR GRASPER |
| Product Code | HIN |
| Date Received | 2018-04-24 |
| Returned To Mfg | 2018-03-12 |
| Model Number | BPS300 |
| Lot Number | GML-00145 |
| Device Expiration Date | 2018-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRACE MANUFACTURING INC. |
| Manufacturer Address | 614 SR 247 RUSSELLVILLE AR 72802 US 72802 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-24 |