MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-14 for CONSTELLATION ULTRAVIT PROBE 8065751438 manufactured by Alcon Research, Ltd. - Houston.
[95067024]
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
[95067025]
An ophthalmic surgeon reported that probe cutter became dull during a procedure, because the surgery took a longer then expected and advanced case. The product was replaced and procedure completed with no patient harm reported. A sample is expected to be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[109684703]
A review of the device history records traceable to the reported lot number indicates that the product was processed and released according to the product? S acceptance criteria. A complaint history examination indicates there was one additional complaint associated with the lot for the reported issue. One probe was returned for evaluation for the report of the poor cutting. The returned sample was visually inspected and deemed nonconforming. The needle is bent approximately 20 degrees. Cut testing was performed and deemed nonconforming. The sample did not cut. Actuation testing was performed and deemed conforming. Aspiration testing was performed and deemed conforming. The probe was disassembled and the components inspected. There is approximately 45 minutes of wear on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos. The inner cutter is slightly bent. Gouge marks observed at the cutting edge, bend area, and several locations along the inner cutter. The complaint evaluation does confirm the sample had a cut issue. The most likely root cause of the poor cutting appears to be from the bent needle and bent inner cutter which most likely occurred due to the probe being used for approximately 45 minutes of surgical use when the vitrectomy portion of the procedure is typically less than 20 minutes. The surgical use appears to have worn and damaged the inner cutter such that the cutter quality had deteriorated. The gouge marks observed at the cutting edge, bend area, and several locations along the inner cutter supports the cutting performance deterioration. This indicates the damage does not appear to be a manufacturing issue. No specific action with regard to this complaint was taken because the reason for the bent needle and bent inner cutter cannot be determined from this evaluation, but was not due to the manufacturing of the probe. All probes are 100% tested for actuation, aspiration, and cut during manufacturing. During the testing of a probe, the probe is visually inspected and a bent needle would be detected and removed from the lot and scrapped. Complaints are reviewed and monitored at regular intervals for any significant adverse trends. No additional action is required at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644019-2017-00840 |
| MDR Report Key | 7118427 |
| Date Received | 2017-12-14 |
| Date of Report | 2018-03-09 |
| Date of Event | 2017-11-29 |
| Date Mfgr Received | 2018-03-01 |
| Device Manufacturer Date | 2017-06-09 |
| Date Added to Maude | 2017-12-14 |
| 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 | MS. NADIA BAILEY |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - HOUSTON |
| Manufacturer Street | 9965 BUFFALO SPEEDWAY |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONSTELLATION ULTRAVIT PROBE |
| Generic Name | VITRECTOMY, INSTRUMENT CUTTER |
| Product Code | MLZ |
| Date Received | 2017-12-14 |
| Returned To Mfg | 2018-01-03 |
| Model Number | NA |
| Catalog Number | 8065751438 |
| Lot Number | 2029185H |
| ID Number | 8065751438 |
| Device Expiration Date | 2019-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-14 |