MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for HARMONIC FOCUS SHEARS HAR9F manufactured by Stryker Sustainability Solutions.
[146211791]
Prior to use on patient, the harmonic device was plugged in and tested and continued to get "error" reading. The device would not open. A new device was obtained and the case continued without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8645216 |
| MDR Report Key | 8645216 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-04-12 |
| Report Date | 2019-05-13 |
| Date Reported to FDA | 2019-05-13 |
| Date Reported to Mfgr | 2019-05-28 |
| Date Added to Maude | 2019-05-28 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | HARMONIC FOCUS SHEARS |
| Generic Name | ULTRASONIC, REPROCESSED |
| Product Code | NLQ |
| Date Received | 2019-05-28 |
| Catalog Number | HAR9F |
| Lot Number | 9270763 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS |
| Manufacturer Address | 1810 W. DRAKE DR. TEMPE AZ 85283 US 85283 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-28 |