MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2015-06-04 for MALYUGIN RING SYSTEM MAL-0002-1 MAL-0002 manufactured by Microsurgical Technology Inc..
[19442807]
After using the malyugin ring, the surgeon demonstrated to a resident how to use it properly when a piece of the ring broke off. There was no patient contact when the piece broke off and it did not cause any harm to the patient as it was not near the patient when this happened.
Patient Sequence No: 1, Text Type: D, B5
[19697731]
The malyugin ring is labeled as a single use device. The surgeon was attempting to use the ring in a demonstration after the ring had already been used in surgery and had been removed from the patient and surgical field at which point the glue joint failed. The device performed according to specifications during the initial use in surgery. There was no impact to the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2015-00018 |
| MDR Report Key | 4819108 |
| Report Source | 00,06 |
| Date Received | 2015-06-04 |
| Date of Report | 2015-06-03 |
| Date of Event | 2015-03-03 |
| Date Mfgr Received | 2015-05-11 |
| Device Manufacturer Date | 2015-01-12 |
| Date Added to Maude | 2015-07-02 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | IRIS CLIP RETRACTOR |
| Product Code | HOC |
| Date Received | 2015-06-04 |
| Returned To Mfg | 2015-05-21 |
| Model Number | MAL-0002-1 |
| Catalog Number | MAL-0002 |
| Lot Number | 066138 |
| Device Expiration Date | 2018-01-01 |
| 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 | 1. Other | 2015-06-04 |