MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-22 for CUTTING LOOP MLE-26-012 manufactured by Gyrus Acmi Inc.
[16075725]
Olympus was informed that during an unspecified procedure, the loop misfired, broke off and fell into the patient. The physician retrieved the broken piece from the patient and the procedure was completed. No patient injury was reported. Olympus followed up with the user facility via telephone and by mail to obtain more detailed information about the reported event, but with no results.
Patient Sequence No: 1, Text Type: D, B5
[16340534]
The device referenced in this report has not yet been returned to olympus for evaluation. The exact cause of the reported event could not be conclusively determined. If additional information is received at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2015-00210 |
| MDR Report Key | 4726916 |
| Report Source | 05,06 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-03-31 |
| Date of Event | 2015-03-31 |
| Date Mfgr Received | 2015-03-31 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2015-06-04 |
| 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 | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUTTING LOOP |
| Generic Name | CUTTING LOOP |
| Product Code | HIN |
| Date Received | 2015-04-22 |
| Model Number | MLE-26-012 |
| Catalog Number | MLE-26-012 |
| Lot Number | 764453FF |
| 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 | 136 TURNPIKE RD SOUTHBOROUGH MA 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-22 |