MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-08-23 for CABLE, MONOPOLAR OPTIMA 006358-901 manufactured by Acmi Corp..
[446614]
Cable broke and caught on fire during a procedure. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124979-2005-00020 |
| MDR Report Key | 706836 |
| Report Source | 07 |
| Date Received | 2005-08-23 |
| Date of Report | 2005-08-22 |
| Date of Event | 2005-07-21 |
| Date Facility Aware | 2005-07-25 |
| Date Mfgr Received | 2005-07-29 |
| Date Added to Maude | 2006-05-03 |
| 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 | GRACIELA DENIS |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042670 |
| Manufacturer G1 | AMCI CORP |
| Manufacturer Street | 3037 MT. PLEASANT STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLE, MONOPOLAR OPTIMA |
| Generic Name | 700 |
| Product Code | HFG |
| Date Received | 2005-08-23 |
| Returned To Mfg | 2005-07-29 |
| Model Number | 006358-901 |
| Catalog Number | 006358-901 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 695895 |
| Manufacturer | ACMI CORP. |
| Manufacturer Address | * RACINE WI * US |
| Baseline Brand Name | MONOPOLAR CABLE, FOR DISPOSABLE ELECTRODES |
| Baseline Generic Name | MONOPOLAR CABLE |
| Baseline Model No | * |
| Baseline Catalog No | 006358-901 |
| Baseline ID | * |
| Baseline Device Family | ELECTROSURGICAL GEN ACCESS. |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-23 |