MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-31 for SONICISION SCD396 manufactured by Covidien Mfg Dc Boulder.
[186018063]
Evaluation summary: one device was returned for evaluation. The returned product did not meet specification as received. Visual inspection of the disposable device revealed that the tip of the waveguide was broken off. The broken piece was not returned. The reported condition was not confirmed because the device needs to be in an activated state to develop fractures. The device stopped working. Investigation personnel performed functional testing on the returned hand piece using a test lab generator and battery. The assembled device returned a green light and a welcome tone, but immediately returned a red light emitting diode (led) indicator with an error tone (alarm activation) when the device was activated. This characteristic indicated that the device was not functional. The waveguide had its tip missing. Investigation personnel concluded that the titanium waveguide was in use when it cracked and broke off, and may have come in contact with any of the following; hemostats, clips, staples, retractors, etc. During use. The investigation identified the cause of the reported event to be user error. The device instructions for use currently contain a warning against contact between the dissector tip and metal objects (hemostats, clips, staples, retractors, etc. ) during activation. Contact with metal objects during use will cause the active blade to crack and may eventually break off. This issue is specific to ultrasonic dissectors. The instructions for use (ifu) advises device users to visually inspect all system components for breaks, cracks, nicks, or other damages prior to use. Ifu also states: do not use damaged components. Use of damaged components may result in injury to the patient or user. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186018064]
According to the reporter, prior to use, the device broke. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2020-00368 |
| MDR Report Key | 9908610 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-16 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2017-10-13 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG DC BOULDER |
| Manufacturer Street | 5920 LONGBOW DR |
| Manufacturer City | BOULDER CO 803013299 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 803013299 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONICISION |
| Generic Name | INSTRUMENT, ULTRASONIC SURGICAL |
| Product Code | LFL |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-12 |
| Model Number | SCD396 |
| Catalog Number | SCD396 |
| Lot Number | 72860021X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG DC BOULDER |
| Manufacturer Address | 5920 LONGBOW DR BOULDER CO 803013299 US 803013299 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |