CONSTELLATION SURGICAL PROCEDURE PAK Adverse Event — Malfunction (MDR 1644019-2020-00226)
CONSTELLATION SURGICAL PROCEDURE PAK Adverse Event — Malfunction (MDR 1644019-2020-00226) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CONSTELLATION SURGICAL PROCEDURE PAK; Generic name: GENERAL SURGERY TRAY (KIT); Manufacturer: ALCON RESEARCH, LLC - HOUSTON.
| Device | CONSTELLATION SURGICAL PROCEDURE PAK |
|---|---|
| Generic name | GENERAL SURGERY TRAY (KIT) |
| Manufacturer | ALCON RESEARCH, LLC - HOUSTON |
| Report number | 1644019-2020-00226 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | ONE OPENED PROBE WAS RECEIVED WITH NO TIP PROTECTOR, IN A ZIP TOP BAG, FOR THE REPORT OF WAS NOT CUTTING EFFECTIVELY DURING SURGERY. AT THE TIME OF RECEIPT IT WAS OBSERVED THAT THE PROBE NEEDLE WAS COMPLETELY BROKEN OFF OF THE REST OF THE PROBE ASSEMBLY. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE NON-CONFORMING WITH THE PROBE NEEDLE COMPLETELY BROKEN OFF AT THE STIFFENER SLEEVE, CO |
| Source | openFDA MAUDE (device adverse events) |
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