MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-08 for VERION DIGITAL MARKER M X-SPM 8065998244 manufactured by Wavelight Gmbh (agps).
[82060984]
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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[82060985]
A nurse reported excessive heat at right side behind screen of monitor was noted. Reporter indicated that the technician had burned her finger when using the digital marker device. It was not reported as to the severity of the injury. Upon additional follow up, the reporter indicated the technician had minor redness to finger, and basically she had snatched her hand back from source of hot plastic.
Patient Sequence No: 1, Text Type: D, B5
[113538099]
The device history records (dhr) for the device was reviewed. The associated device was released based on company acceptance criteria. During the field service engineer (fse) on-site visit, the reported injury could not be confirmed. The device was tested and the extreme heat could not be reproduced. The device was replaced as a pre-cautionary measure. Evaluation regarding temperature distribution on the backside of the device were reviewed. A maximum temperature of 50. 4? C has been measured on the same product type, and a warning sticker is placed at the hot location. However a description and respective warning is not available in the user manual. No technical root cause could be determined. An internal investigation has been opened to add warning information to the user manual. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[113538100]
Additional information received from reporter states basic first aid treatment applied to finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010300699-2017-00024 |
| MDR Report Key | 6774336 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-08 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-08-09 |
| Date Added to Maude | 2017-08-08 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERION DIGITAL MARKER M |
| Generic Name | MARKER, OCULAR |
| Product Code | FTH |
| Date Received | 2017-08-08 |
| Returned To Mfg | 2017-08-24 |
| Model Number | X-SPM |
| Catalog Number | 8065998244 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-08-08 |