MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-14 for 23GA CORONA WIDE FIELD ENDOILLUMINATOR 56.12.23P manufactured by Bausch + Lomb.
[120380997]
The device involved in the reported event was requested however to date it has not been received. The lot device manufacturing records were reviewed and found to be acceptable.
Patient Sequence No: 1, Text Type: N, H10
[120380998]
A report from a user facility in ireland stated that during one case, the tip of the light pipe broke inside the patient's eye. The surgeon was able to retrieve the small fragment from the eye. The patient did not require any additional intervention and did not suffer any consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001932402-2018-00014 |
| MDR Report Key | 7878707 |
| Date Received | 2018-09-14 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-08-15 |
| Device Manufacturer Date | 2017-02-03 |
| Date Added to Maude | 2018-09-14 |
| 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 | JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | SYNERGETICS |
| Manufacturer Street | 3845 CORPORATE CENTRE DRIVE |
| Manufacturer City | O''FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63368 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 23GA CORONA WIDE FIELD ENDOILLUMINATOR |
| Generic Name | DISPOSABLE FIBER OPTIC ENDOILLUMINATOR |
| Product Code | MPA |
| Date Received | 2018-09-14 |
| Model Number | 56.12.23P |
| Catalog Number | 56.12.23P |
| Lot Number | M0006743 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-14 |