MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for HARMONIC HD 1000I SHEARS 36CM SHAFT HARHD36 manufactured by Ethicon Endo-surgery, Llc..
[146375614]
(b)(4). Batch # r94p7g. Investigation summary: the device was returned with the distal tip of the blade broken off and not returned. The remaining blade portion was scratched, and with evidence of contact with metal in or out of the operative field. This blade tip portion may have broken off of the device during transport to our analysis site. During functional testing on gen11 an alert screen was displayed. A probable cause of the device stop activating and display an alert screen is blade damage. The device was analyzed, and it was determined that it was used in more than one generator. The device is intended to be used with a single generator. If the device is connected to a different generator an alert screen will be displayed indicating to replace the instrument / no instrument uses remaining / restart generator. The device was disassembled to inspect the internal components and no anomalies were found. Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, staples or clips during the procedure. Once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage. This in turn can result in failing the pre-run test with the generator and displaying an alert screen. These alert screens that can result are such as,? Blade error detected? Or "relaxed pressure on blade" or " removed instrument from patient" followed by a? Replace instrument? Screen later in the procedure. Continued usage of the damage blade can result in a broken blade. This device is packaged and sterilized for single use only. Multiple patient use may compromise the device integrity or create a risk of contamination that, in turn, may result in patient injury or illness. A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Patient Sequence No: 1, Text Type: N, H10
[146375615]
It was reported that during an endometriosis procedure, the shears stopped working during the surgical procedure. An error message was displayed asking to replace the instrument. Another similar product was used to continue the procedure. There were no complications or harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2019-19333 |
| MDR Report Key | 8640749 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-04-16 |
| Date Mfgr Received | 2019-05-22 |
| Device Manufacturer Date | 2018-10-18 |
| Date Added to Maude | 2019-05-24 |
| 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 | MR. MILTON GARRETT |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Postal | 00969 |
| Manufacturer Phone | 5133378865 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HARMONIC HD 1000I SHEARS 36CM SHAFT |
| Generic Name | INSTRUMENT, ULTRASONIC SURGICAL |
| Product Code | LFL |
| Date Received | 2019-05-24 |
| Returned To Mfg | 2019-05-21 |
| Catalog Number | HARHD36 |
| Lot Number | R94U9T |
| 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 | 2019-05-24 |