MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-22 for CURVED MEMBRANE SCRAPER 338.25P manufactured by Alcon Grieshaber Ag.
[95816133]
No sample has been received by manufacturing for evaluation. 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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95816134]
A doctor reported that an ophthalmic membrane scraper was difficult to insert through the entry trocar during vitrectomy surgery resulting in the loop portion detaching from the device into the patient's eye. The detached loop was detected and removed from the patient's eye during the procedure. An alternate scraper was obtained in order to complete the procedure. Patient impact information is unknown. Additional information has been requested. Additional information received confirmed that there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2017-00033 |
| MDR Report Key | 7143021 |
| Date Received | 2017-12-22 |
| Date of Report | 2018-01-02 |
| Date of Event | 2017-12-07 |
| Date Mfgr Received | 2018-01-02 |
| Device Manufacturer Date | 2017-02-03 |
| Date Added to Maude | 2017-12-22 |
| 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. NADIA BAILEY |
| 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 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 | 2017-12-22 |
| Model Number | NA |
| Catalog Number | 338.25P |
| Lot Number | F145790 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-12-22 |