MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-12 for HOFFMAN/AHMED HORIZONTAL MICRO-SCISSORS, CURVED, 23 GAUGE DFH-0008 manufactured by Microsurgical Technology, Inc..
[114056024]
The device evaluation showed that the blade was broken off from the top of the tine, the other blade broke at the base of the tine. There was moderate corrosion at the site of the fractures and throughout the cannula of the scissors. Small rust spots visible and corrosion pits. The mouth of the cannula is deformed, flared where the tines had made contact, indicating that scissors came into contact with hard object. Device failure is due to corrosion and inadequate use, these scissors are not made to cut the iol due to how hard the iol is.
Patient Sequence No: 1, Text Type: N, H10
[114056025]
The customer reported the blade was caught in the iol and fell off in the eye during cataract surgery. The blade and iol was removed during surgery and no known harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2018-00024 |
| MDR Report Key | 7684111 |
| Date Received | 2018-07-12 |
| Date of Report | 2018-07-12 |
| Device Manufacturer Date | 2012-02-29 |
| Date Added to Maude | 2018-07-12 |
| 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. CECIL CHRISINGER |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| 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 |
| Generic Name | OPHTHALMIC SCISSORS |
| Product Code | HNF |
| Date Received | 2018-07-12 |
| Returned To Mfg | 2018-07-07 |
| Model Number | DFH-0008 |
| Catalog Number | DFH-0008 |
| Lot Number | 045617 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-07-12 |