MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-26 for SUCTION CANNULA PROBE 266QDHC SAME manufactured by American-hydro Surgical.
[21714486]
Our initial evaluation of this complaint, we did not identify it as mdr reportable. However, since the manufacturer has filed it as mdr, we decided to do the same. A quick-disconnect probe came off the trumpet valve during a pelviscopy procedure, spraying the surgeon's mask and face with "bloody fluid".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-1994-00026 |
| MDR Report Key | 22852 |
| Date Received | 1994-07-26 |
| Date of Report | 1994-07-13 |
| Date of Event | 1994-05-15 |
| Date Facility Aware | 1994-06-01 |
| Report Date | 1994-07-13 |
| Date Reported to FDA | 1994-07-13 |
| Date Reported to Mfgr | 1994-07-13 |
| Date Added to Maude | 1995-06-26 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUCTION CANNULA PROBE |
| Generic Name | QUICK DISCONNECT PROBE |
| Product Code | HFN |
| Date Received | 1994-07-26 |
| Returned To Mfg | 1994-06-13 |
| Model Number | 266QDHC |
| Catalog Number | SAME |
| Lot Number | 0293 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 23074 |
| Manufacturer | AMERICAN-HYDRO SURGICAL |
| Manufacturer Address | 430 COMMERCE DRIVE DELRAY BEACH FL 33445 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-26 |