MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-27 for ULTRA FLOW IA HAND PIECE 0123 manufactured by Alcon.
[74051983]
Surgeon reported during the case the alcon infiniti machine and ia hand piece were not working properly in the suction mode to remove the cataract. The other ia hand piece was dirty from the previous patient and was not washed as the case we were working on was the last one of the day. Central sterile was called and the other hand piece was washed and put in sterilizer. That process was 20 min. Surgeon continued to operate as patient was receiving conscious sedation anesthesia. Added procedure included; anterior vitrectomy and anterior chamber lens implantation (completed as the other hand piece came up from sterilization). Vantage outsourcing rep. Investigated the problem after the surgery to determine if it was the infiniti machine or the ia hand piece. It was found to be the hand piece malfunction. There was no suction on the handpiece to suction out the cataract, the surgeon had to do a manual retrieval. Dates of use: (b)(6) 2017. Diagnosis or reason for use: cataract right eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069383 |
| MDR Report Key | 6529437 |
| Date Received | 2017-04-27 |
| Date of Report | 2017-04-14 |
| Date of Event | 2017-04-11 |
| Date Added to Maude | 2017-04-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRA FLOW IA HAND PIECE |
| Generic Name | IA HAND PIECE/VITRECTOMY INSTRUMENT CUTTER |
| Product Code | MLZ |
| Date Received | 2017-04-27 |
| Returned To Mfg | 2017-04-11 |
| Model Number | 0123 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-27 |