MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for EDGEPLUS VALVED ENTRY SYSTEM 8065751657 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
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Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
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A nurse reported that the valved trocar leaked during a procedure. The product was replaced and procedure completed with no patient harm. Pictures of leaking valved trocars provided.
Patient Sequence No: 1, Text Type: D, B5
[118600208]
No sample has been returned for evaluation; however, photos of the product are attached to the parent file and have been reviewed by the manufacturing site. The photos confirm that one of the trocars is leaking. A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product? S acceptance criteria. A complaint history examination indicates there is one additional complaint associated with the lot for the reported issue. The provided photos confirm the leaking trocar, as was reported by the customer. However, no sample was returned and the device history record review of the lot number provided indicated product was processed and released according to the product? S acceptance criteria, therefore the root cause for the defect experienced by the customer cannot be determined. The exact root cause for this complaint is unknown. Investigations have been completed and manufacturing process enhancements have been implemented in order to improve the performance of the valves. Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken. No additional action is required at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2018-01225 |
| MDR Report Key | 7593812 |
| Date Received | 2018-06-12 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-08-17 |
| Device Manufacturer Date | 2017-11-02 |
| Date Added to Maude | 2018-06-12 |
| 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. BRYAN BLAKE |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EDGEPLUS VALVED ENTRY SYSTEM |
| Generic Name | CANNULA, TROCAR, OPHTHALMIC |
| Product Code | NGY |
| Date Received | 2018-06-12 |
| Model Number | NA |
| Catalog Number | 8065751657 |
| Lot Number | 17034959X |
| ID Number | 380657516575 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-12 |