MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-16 for CONSTELLATION SURGICAL PROCEDURE PAK 8065752451 manufactured by Alcon Research, Llc - Houston.
[185942640]
At a minimum, weekly notifications are sent to affiliates for sample status, completion of pending follow-up activities and completed investigations by vpa/gss. A sample has been shipped; however, it has not been received for evaluation at the manufacturing site. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185942641]
A customer reported that the cutter did not actuate and cutting failure occurred during surgery. The condition of aspiration is unknown. The surgery was completed after replacing the pak with another one. There's no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644019-2020-00145 |
| MDR Report Key | 9836901 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-11-11 |
| Date Added to Maude | 2020-03-16 |
| 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 | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | ALCON RESEARCH, LLC - 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 | 3 |
| Brand Name | CONSTELLATION SURGICAL PROCEDURE PAK |
| Generic Name | GENERAL SURGERY TRAY (KIT) |
| Product Code | LRO |
| Date Received | 2020-03-16 |
| Model Number | NA |
| Catalog Number | 8065752451 |
| Lot Number | 2337312H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |