MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-07 for HOFFMAN/AHMED HORIZONTAL MICRO-SCISSORS, CURVED, 23 GAUGE WITH INSPECTION PORT DFH-0008 manufactured by Microsurgical Technology Inc.
[42681086]
The device evaluation showed that the scissor was used to cut to hard of an object, an iol. This scissor is indicated to cut soft tissue and objects in the eye per the dfu.
Patient Sequence No: 1, Text Type: N, H10
[42681087]
Ophthalmic scissor blade broke in the eye while cutting a lens. The blade was removed without issue and there was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2016-00003 |
| MDR Report Key | 5556336 |
| Date Received | 2016-04-07 |
| Date of Report | 2016-04-06 |
| Date Mfgr Received | 2016-03-09 |
| Device Manufacturer Date | 2012-02-17 |
| Date Added to Maude | 2016-04-07 |
| 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 |
| Reporter Occupation | MEDICAL ASSISTANT |
| 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 | HOFFMAN/AHMED HORIZONTAL MICRO-SCISSORS, CURVED, 23 GAUGE WITH INSPECTION PORT |
| Generic Name | OPHTHALMIC SCISSOR |
| Product Code | HNF |
| Date Received | 2016-04-07 |
| Returned To Mfg | 2016-03-24 |
| Model Number | DFH-0008 |
| Catalog Number | DFH-0008 |
| Lot Number | 045283 |
| 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 | 2016-04-07 |