MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-02 for OSHER MALYUGIN MANIPULATOR MAL-0003 manufactured by Microsurgical Technology Inc.
[30570128]
The device evaluation showed that the manipulator experienced extreme forces that bent and racked the ball of the device prior to use. The damage most likely occured during maintenance.
Patient Sequence No: 1, Text Type: N, H10
[30570129]
A piece of the osher/malyugin manipulator came off in the patient's eye. Piece was removed without issue and surgery was completed as planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2015-00033 |
| MDR Report Key | 5195832 |
| Date Received | 2015-11-02 |
| Date of Report | 2015-10-30 |
| Date Mfgr Received | 2015-10-02 |
| Date Added to Maude | 2015-11-02 |
| 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 | MR. ROBERT MAY |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| Manufacturer G1 | MICROSURGICAL TECHNOLOGY INC |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OSHER MALYUGIN MANIPULATOR |
| Generic Name | OPHTHALMIC HOOK |
| Product Code | HNQ |
| Date Received | 2015-11-02 |
| Returned To Mfg | 2015-10-13 |
| Model Number | MAL-0003 |
| Catalog Number | MAL-0003 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY INC |
| Manufacturer Address | 8415 154TH AVE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-02 |