MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-21 for PACKER CHANG IOL CUTTER DFH-0012 manufactured by Microsurgical Technology Inc.
[68223639]
The device was returned dirty and corroded. The cannula of the scissor was cracked and rusted. The malfunction was due to improper cleaning and maintenance. There was no impact to the patient.
Patient Sequence No: 1, Text Type: N, H10
[68223900]
During surgery the surgeon noted hearing a snapping sound coming from the scissors. The surgeon discontinued use of the device and there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2017-00003 |
| MDR Report Key | 6347811 |
| Date Received | 2017-02-21 |
| Date of Report | 2017-02-20 |
| Date of Event | 2017-01-20 |
| Date Mfgr Received | 2017-01-20 |
| Device Manufacturer Date | 2014-10-27 |
| Date Added to Maude | 2017-02-21 |
| 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 | PACKER CHANG IOL CUTTER |
| Generic Name | OPHTHALMIC SCISSOR |
| Product Code | HNF |
| Date Received | 2017-02-21 |
| Returned To Mfg | 2017-02-14 |
| Model Number | DFH-0012 |
| Catalog Number | DFH-0012 |
| Lot Number | 064410 |
| 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 | 2017-02-21 |