MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-21 for SOFT I/A S-IA-02020 manufactured by Microsurgical Technology, Inc..
[112437783]
The device was evaluated and it was found that the hub of the cannula was damaged. The hub appeared to have been gripped by forceps or pliers to tighten and/or loosen the tip onto the handpieces. The gripping caused the metal to strip off and be introduced into the eye. The metal piece was easily aspirated from the eye and there was no patient impact.
Patient Sequence No: 1, Text Type: N, H10
[112437784]
Customer reported that during cataract surgery, the patient had a particle in the anterior chamber. There was no patient impact and the particle was aspirated from the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2018-00019 |
| MDR Report Key | 7625878 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-21 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-05-30 |
| Date Mfgr Received | 2018-05-30 |
| Device Manufacturer Date | 2018-01-04 |
| Date Added to Maude | 2018-06-21 |
| 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. CECIL CHRISINGER |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT I/A |
| Generic Name | OPHTHALMIC CANNULA |
| Product Code | HMX |
| Date Received | 2018-06-21 |
| Returned To Mfg | 2018-06-19 |
| Model Number | S-IA-02020 |
| Catalog Number | S-IA-02020 |
| Lot Number | 010218 |
| 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 | 2018-06-21 |