MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-28 for HOFFMAN/AHMED HORIZONTAL MICRO-SCISSORS, CURVED, 23 GAUGE WITH INSPECTION PORT DFH-0008 manufactured by Microsurgical Technology, Inc..
[56357466]
The device evaluation showed that the blade was broken about midway on the tine. Broken blade was not returned. Instrument was returned dirty, with dried residue on the exterior and interior. Small rust spots visible, and remaining blade appears rusty with a corrosion pit on the surface. Fractured surface of the broken tine has a darkened spot, which may correspond with prior corrosion pits. Cannula is slightly bent at base. Device failure is due to corrosion as a result of poor maintenance.
Patient Sequence No: 1, Text Type: N, H10
[56357467]
The surgeon reported that the blade "fell off" in the eye during surgery. The blade was removed and there was no known harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2016-00017 |
| MDR Report Key | 5984254 |
| Date Received | 2016-09-28 |
| Date of Report | 2016-09-26 |
| Date of Event | 2016-08-25 |
| Date Mfgr Received | 2016-09-07 |
| Device Manufacturer Date | 2013-03-06 |
| Date Added to Maude | 2016-09-28 |
| 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. JOHN RAY |
| 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 SCISSORS |
| Product Code | HNF |
| Date Received | 2016-09-28 |
| Returned To Mfg | 2016-09-16 |
| Model Number | DFH-0008 |
| Catalog Number | DFH-0008 |
| Lot Number | 051735 |
| 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 | 1. Other | 2016-09-28 |