MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for STRYKER HARMONIC HARH45 manufactured by Stryker Sustainability Solutions Lakeland.
[181159458]
Harmonic ace + 7 shears was not working, tried to disconnect from the harmonic machine and plugged it back in but still did not work. It made a weird sound and did produce some smoke.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9763938 |
MDR Report Key | 9763938 |
Date Received | 2020-02-27 |
Date of Report | 2020-01-10 |
Date of Event | 2020-01-07 |
Report Date | 2020-01-17 |
Date Reported to FDA | 2020-01-17 |
Date Reported to Mfgr | 2020-02-27 |
Date Added to Maude | 2020-02-27 |
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 | OTHER HEALTH CARE PROFESSIONAL |
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 | STRYKER HARMONIC |
Generic Name | SCALPEL, ULTRASONIC, REPROCESSED |
Product Code | NLQ |
Date Received | 2020-02-27 |
Catalog Number | HARH45 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | 1 DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
Manufacturer Address | 5300 REGION CT LAKELAND FL 33815 US 33815 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-27 |