MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-05-20 for CUTTING LOOP MLE-24-012 manufactured by Gyrus Acmi Inc..
[4613564]
The user facility reported that during a hysteroscopy procedure a piece of the device broke off inside the pt. The pt cavity and tissue was searched. However, nothing was found. The procedure was completed using the same device no pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[11803385]
The device referenced in this report was not returned to olympus for eval. If add'l info is received at a later time this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00208 |
| MDR Report Key | 3839287 |
| Report Source | 06 |
| Date Received | 2014-05-20 |
| Date of Report | 2014-05-09 |
| Date of Event | 2014-05-09 |
| Date Mfgr Received | 2014-05-09 |
| Device Manufacturer Date | 2009-07-21 |
| Date Added to Maude | 2014-05-30 |
| 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 SCHAMBACK |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Manufacturer G1 | GYRUS ACMI INC. |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01772 2104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUTTING LOOP |
| Generic Name | LOOP |
| Product Code | HIN |
| Date Received | 2014-05-20 |
| Model Number | MLE-24-012 |
| Catalog Number | MLE-24-012 |
| Lot Number | 111153GB |
| 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 | 1. Other | 2014-05-20 |