MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-03 for CUSHING, 19CM (7.50"), 0.7MM * N19C07 manufactured by J. Jamner Surgical Instruments, Inc..
[446651]
Physician reported that on the cushing style bipolar, the end of the bipolar begin to separated when pushing the two sides together all the way.
Patient Sequence No: 1, Text Type: D, B5
[16478612]
Product id for device received was identified as n19c15 not n19c07 as initially reported. The mfr of the device has been identified and provided herein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2006-00018 |
| MDR Report Key | 710105 |
| Date Received | 2006-05-03 |
| Date of Report | 2006-05-01 |
| Report Date | 2006-05-01 |
| Date Added to Maude | 2006-05-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSHING, 19CM (7.50"), 0.7MM |
| Generic Name | NON-STICK BIPOLAR |
| Product Code | LYT |
| Date Received | 2006-05-03 |
| Model Number | * |
| Catalog Number | N19C07 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 699153 |
| Manufacturer | J. JAMNER SURGICAL INSTRUMENTS, INC. |
| Manufacturer Address | * HAWTHORNE NY * US |
| Baseline Brand Name | CUSHING, 19CM (7.50"), 0.7M |
| Baseline Generic Name | NON-STICK BIPOLAR |
| Baseline Model No | * |
| Baseline Catalog No | N19C07 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-03 |