MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-10-22 for CUTTING LOOP MLE-26-012 manufactured by Gyrus Acmi, Inc..
[20651696]
During a transurethral resection of the prostate procedure they experienced arching with this electrode. No pt injury and no parts were left behind in the pt.
Patient Sequence No: 1, Text Type: D, B5
[20964699]
At the time of this report, multiple attempts to obtain further info from the hospital have been unsuccessful, and the device has not yet been returned for eval. As a result, a determination cannot be made at this time. If further info becomes available, gyrus amci will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006159227-2012-00011 |
| MDR Report Key | 2804100 |
| Report Source | 06 |
| Date Received | 2012-10-22 |
| Date of Report | 2012-10-09 |
| Date of Event | 2012-10-03 |
| Date Mfgr Received | 2012-10-09 |
| Date Added to Maude | 2012-10-26 |
| 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 | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD. |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI, INC. |
| Manufacturer Street | CARRETERA SALTILLO-ZACATECAS KM 4.5 |
| Manufacturer City | SALTILLO, COAHUILA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUTTING LOOP |
| Generic Name | CUTTING LOOP |
| Product Code | CBN |
| Date Received | 2012-10-22 |
| Model Number | MLE-26-012 |
| Catalog Number | MLE-26-012 |
| Lot Number | 361427 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | CARRETERA SALTILLO-ZACATECAS KM 4.5 LA ANGOSTURA, C.P. MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-22 |