MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-07-11 for SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCLUDING ILLUMINATED SCLERAL DEPRESSO 3269.SBS06 manufactured by D.o.r.c International.
[79911880]
Device history lot review: unable to perform since the lot number is unknown. Sample analysis: it was determined on 13jun2017 that an examination of the returned light fiber revealed that the coating was melted as a result of direct contact with a hot object. The damaged coating causes the fiber not to function in a proper manner. Additionally, it was identified that the damage most likely originated from the outside rather than from within the fiber itself and strengthens our observation that an external heat source was the cause. The location of the damage was found to be located somewhere halfway between the connector and the hand piece and not anywhere near the patients eye. Conclusion: the complaint has not been found acknowledged. It is unknown when this incident occurred. We are not aware of any injury that occurred. Should any further information be obtained a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[79911881]
An initial report has been received reporting "upon arriving the office manager at the center handed me a stack of bad product. " no further information was reported. The sample for this complaint has been returned and evaluated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2017-00005 |
| MDR Report Key | 6703233 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-07-11 |
| Date of Report | 2017-06-13 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2017-06-13 |
| Date Added to Maude | 2017-07-11 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS LAURA SMITH |
| Manufacturer Street | 10 CONTINENTAL DR |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal | 03833 |
| Manufacturer Phone | 6037786929 |
| Manufacturer G1 | DUTCH OPHTHALMIC USA |
| Manufacturer Street | 10 CONTINENTAL DR |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03833 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCLUDING ILLUMINATED SCLERAL DEPRESSO |
| Generic Name | FIBER OPTIC ENDOILLUMINATION PROBE |
| Product Code | FFS |
| Date Received | 2017-07-11 |
| Catalog Number | 3269.SBS06 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O.R.C INTERNATIONAL |
| Manufacturer Address | KERKWEG 47E ZUIDLAND, NETHERLANDS 3214VC NL 3214 VC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-11 |