MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for HARMONIC ACE HAR36 manufactured by Stryker Sustainability Solutions, Inc..
[142611457]
Prompted to retighten and would not register with generator. When they tried to unscrew the handpiece from the cord the handpiece broke. Manufacturer response for harmonic, ethicon (per site reporter): they will credit us for the device and initiate a quality control investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8535248 |
| MDR Report Key | 8535248 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-03-25 |
| Report Date | 2019-04-17 |
| Date Reported to FDA | 2019-04-17 |
| Date Reported to Mfgr | 2019-04-22 |
| Date Added to Maude | 2019-04-22 |
| 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 | HARMONIC ACE |
| Generic Name | SCALPEL, ULTRASONIC, REPROCESSED |
| Product Code | NLQ |
| Date Received | 2019-04-22 |
| Returned To Mfg | 2019-04-02 |
| Catalog Number | HAR36 |
| Lot Number | 9781290 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| Manufacturer Address | 5300 REGION CT LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-22 |