MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for HARMONIC HD 1000I SHEARS 36CM SHAFT HARHD36 manufactured by Ethicon Endo-surgery, Llc..
| Report Number | 3005075853-2020-01749 |
| MDR Report Key | 9861358 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-09-18 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Country | * |
| Manufacturer Postal | 00969 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARMONIC HD 1000I SHEARS 36CM SHAFT |
| Generic Name | INSTRUMENT, ULTRASONIC SURGICAL |
| Product Code | LFL |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-02 |
| Model Number | HARHD36 |
| Catalog Number | HARHD36 |
| Lot Number | T94H1X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Address | 475 CALLE C GUAYNABO 00969 * 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |