MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-28 for VERION DIGITAL MARKER M X-SPM 8065998244 manufactured by Wavelight Gmbh (agps).
[81475086]
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
[81475087]
A doctor reported there is a jump in axis by about 30 degrees. Upon follow up, surgery went well and was completed. No patient harm was reported. The physician decided the correct setting for the axis. There are two related reports. This report addresses the (b)(6) 2017 event and another manufacturer report will be filed for the occasionally occurrences.
Patient Sequence No: 1, Text Type: D, B5
[113535440]
No anomalies found by review of device history record. Product met all specifications when released. Use error which was caused by a misunderstanding between the local clinical applications specialist (cas) and the surgeon which could be clarified with a re-training. Additionally, the data analysis showed inappropriate reference and surgery image used for registration on the system which the cas will re-train the site on how to follow the instructions correctly. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[113536481]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[113536482]
Upon additional follow up, the nurse provided that the left eye was affected. Nurse informed that the last setting of the axis was 170?. It was not reproducible for nurse whether this setting was made manually or whether it was a default setting.
Patient Sequence No: 1, Text Type: D, B5
[113536745]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2017-00019 |
| MDR Report Key | 6750584 |
| Date Received | 2017-07-28 |
| Date of Report | 2017-12-01 |
| Date of Event | 2017-07-04 |
| Date Mfgr Received | 2017-11-24 |
| Date Added to Maude | 2017-07-28 |
| 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 | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW D-14513 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-14513 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | WAVELIGHT GMBH (AGPS) |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW 14513 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14513 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VERION DIGITAL MARKER M |
| Generic Name | MARKER, OCULAR |
| Product Code | FTH |
| Date Received | 2017-07-28 |
| Model Number | X-SPM |
| Catalog Number | 8065998244 |
| Lot Number | ASKU |
| ID Number | 2.6.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH (AGPS) |
| Manufacturer Address | RHEINSTRASSE 8 TELTOW 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-28 |