MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-27 for ULTRASONIC DISSECTOR SCD396 manufactured by Covidien Lp.
[37236035]
(b)(4). To date the incident sample has not been received for evaluation. If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[37236036]
The customer reported that during the procedure, a piece of the active waveguide disengaged during the cleaning of the jaws with gauze. Nothing fell into the patient cavity and there was no patient injury..
Patient Sequence No: 1, Text Type: D, B5
[48946105]
(b)(4). One used sonicision cordless ultrasonic dissector was returned for evaluation. Visual inspection of the disposable hand piece revealed that the waveguide had fractured and the tip had broken off. The broken tip did not fall into cavity but was not returned. The reported condition was confirmed. The waveguide was inspected under magnification to identify the point of initial contact that caused the fracture and eventual break. Investigation personnel concluded that the titanium waveguide was in use when it fractured. Further investigation revealed that the dissector tip came in contact with a metal object (hemostats, clips, staples, retractors, etc. ) during activation. This contact caused the waveguide to crack and eventually break off. 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. This issue is specific to ultrasonic dissectors.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00072 |
| MDR Report Key | 5392567 |
| Date Received | 2016-01-27 |
| Date of Report | 2016-01-19 |
| Date of Event | 2016-01-19 |
| Date Mfgr Received | 2016-06-30 |
| Device Manufacturer Date | 2014-07-07 |
| Date Added to Maude | 2016-01-27 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASONIC DISSECTOR |
| Generic Name | ULTRASONIC DISSECTOR |
| Product Code | BWA |
| Date Received | 2016-01-27 |
| Returned To Mfg | 2016-06-29 |
| Model Number | SCD396 |
| Catalog Number | SCD396 |
| Lot Number | 41680113X |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-27 |