MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-29 for 23G HOFFMAN/AHMED MICRO-SCISSORS DFH-0010 manufactured by Microsurgical Technology Inc.
[49237639]
The device was returned showing signs of heavy use. The internal components were corroded and dirty.
Patient Sequence No: 1, Text Type: N, H10
[49237640]
The facility reported that a mst scissor had broken in the patient's eye during cataract surgery. There was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3019924-2016-00015 |
MDR Report Key | 5760670 |
Date Received | 2016-06-29 |
Date of Report | 2016-06-29 |
Date Mfgr Received | 2016-06-02 |
Device Manufacturer Date | 2012-02-24 |
Date Added to Maude | 2016-06-29 |
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 | 23G HOFFMAN/AHMED MICRO-SCISSORS |
Generic Name | OPHTHALMIC SCISSOR |
Product Code | HNF |
Date Received | 2016-06-29 |
Returned To Mfg | 2016-06-10 |
Model Number | DFH-0010 |
Catalog Number | DFH-0010 |
Lot Number | 045576 |
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 | 2016-06-29 |