MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for HARMONIC HARHD36 manufactured by Ethicon Endo-surgery, Llc.
[185521334]
Harmonic handpiece 1000i shears would not make a seal. Pad on harmonic started to peal off handpiece. Switched to reprocessed harmonic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9896919 |
| MDR Report Key | 9896919 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-26 |
| Report Date | 2020-03-12 |
| Date Reported to FDA | 2020-03-12 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Generic Name | INSTRUMENT, ULTRASONIC SURGICAL |
| Product Code | LFL |
| Date Received | 2020-03-30 |
| Model Number | HARHD36 |
| Catalog Number | HARHD36 |
| Lot Number | P91J0P |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Address | 475 CALLE C GUAYNABO PR 00969 US 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |