MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-08-01 for 27G VIVID CHANDELIER 56.54.27P manufactured by Bausch + Lomb.
[81487890]
The "bump/convex" as described by the user is the stretch transition in the fiber. Visual inspection of the returned product found the stretch location was not within blueprint tolerance. Stretch location is supposed to be 0. 365 +. 020/-. 005. The stretch location of the returned fiber measured 1. 950 from tip to beginning of stretch. Root cause of the failure is attributed to fiber was not trimmed prior to coning operation. The fiber portion that is inserted into the eye is checked for cone length, fiber diameter, cinch/valve placement, illumination image, and illumination output. The location of the stretch transition at the time of manufacture was not noted as a critical feature and was not an inspection point. Though the stretch transition can be used to ensure that the fiber does not enter the eye beyond 10 mm, it was designed to ensure that minimal light leaked out from the stretched portion outside of the fiber. Similar products have no stretch transition and can be inserted to any depth that the surgeon desires. The stretch transition on this product was not intended to be used as a hard stop, however, as it appears the users have a new expectation, we have since incorporated this as a new inspection point for all future product built. In addition, all in-stock product was inspected with zero additional defects found, and dcr 11577 was initiated to add additional inspection steps and work instruction comments for stretch location. A review of the complaint database found no other similar failures have been reported.
Patient Sequence No: 1, Text Type: N, H10
[81487911]
The user facility reported the bump/convex on the 27g vivid chandelier that is normally located at approximately 10 mm from the tip of the probe was instead located at approximately 5 cm from the tip which allowed the probe to be inserted more deeply into the eye than expected. The patient did not require additional treatment and there was no adverse effect after the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001932402-2017-00007 |
| MDR Report Key | 6756585 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-01 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-07-05 |
| Date Mfgr Received | 2017-07-10 |
| Device Manufacturer Date | 2017-02-23 |
| Date Added to Maude | 2017-08-01 |
| 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. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 636226-322 |
| Manufacturer G1 | SYNERGETICS |
| Manufacturer Street | 3845 CORPORATE CENTRE DR. |
| 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 | 3 |
| Brand Name | 27G VIVID CHANDELIER |
| Generic Name | ENDOILLUMINATOR |
| Product Code | MPA |
| Date Received | 2017-08-01 |
| Returned To Mfg | 2017-07-25 |
| Model Number | 56.54.27P |
| Lot Number | M0007543 |
| ID Number | NI |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-01 |