MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-19 for CURVED MEMBRANE SCRAPER 338.23 manufactured by Alcon Grieshaber Ag.
[57923632]
The sample has not yet been received for evaluation. The investigation is in progress. The device history record for the affected lot was reviewed. No abnormalities that could have contributed to this event were found in the production documentation and the sample was released according to the manufacturer's acceptance criteria. A 100% final inspection is performed for this product. 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. Additional information has been requested. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[57923633]
A materials manager reported that when an ophthalmic membrane scrapper would not fit through the entry trocar during surgery, it was noted to exhibit a burr on the end. An alternate device was obtained in order to continue the procedure with no impact to the patient. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2016-00018 |
| MDR Report Key | 6042347 |
| Date Received | 2016-10-19 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-10-03 |
| Date Mfgr Received | 2016-10-03 |
| Device Manufacturer Date | 2015-11-06 |
| Date Added to Maude | 2016-10-19 |
| 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 | MS. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| Manufacturer G1 | ALCON GRIESHABER AG |
| Manufacturer Street | WINKELRIEDSTRASSE 52 |
| Manufacturer City | SCHAFFHAUSEN 8203 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CURVED MEMBRANE SCRAPER |
| Generic Name | SPATULA, OPHTHALMIC |
| Product Code | HND |
| Date Received | 2016-10-19 |
| Model Number | NA |
| Catalog Number | 338.23 |
| Lot Number | F133241 |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON GRIESHABER AG |
| Manufacturer Address | WINKELRIEDSTRASSE 52 SCHAFFHAUSEN 8203 SZ 8203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-19 |