MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-06-11 for MONOPOLAR CABLE 10 FEET 600290 manufactured by J. Jamner Surgical Instruments.
[1406137]
The customer initially reports that there is a possible electrical leakage. Electrode is not cauterizing. No patient injury. On (b)(6) 2010, the clinical manager of the operating room reports via telephone that there was no patient incident/event except that there was apparently no current going to the electrode being used with this monopolar cable, the device did not activate. She confirmed no patient harm, device did not work. This mdr is being filed only because an mdr was found on a 2 year look back.
Patient Sequence No: 1, Text Type: D, B5
[8634724]
This mdr is being filed for this product only because an mdr was found on two year look back. To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2430952-2010-00025 |
| MDR Report Key | 1737918 |
| Report Source | 06 |
| Date Received | 2010-06-11 |
| Date of Report | 2010-06-11 |
| Date Mfgr Received | 2010-06-03 |
| Date Added to Maude | 2011-02-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOPOLAR CABLE 10 FEET |
| Generic Name | ELECTROSURGICAL COAGULATION |
| Product Code | HFG |
| Date Received | 2010-06-11 |
| Catalog Number | 600290 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J. JAMNER SURGICAL INSTRUMENTS |
| Manufacturer Address | HAWTHORNE NY 10532 US 10532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-11 |