MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-30 for ULTRASONIC DISSECTOR SCD396 manufactured by Covidien Lp.
[32421283]
(b)(4). The return of the incident sample has been requested. To date it has not been received for evaluation. Additional questions in regard to the incident have also been asked. 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
[32421284]
The customer reported that during a prostatectomy, the tip of the active waveguide disengaged. There was no patient injury. Additional questions regarding the device and incident have been asked.
Patient Sequence No: 1, Text Type: D, B5
[132547857]
Additional information: (udi #), (name, email), (phone #, fax #), evaluation summary: one device was returned for evaluation. The returned product did not meet specification as received. The visual inspection of the disposable device revealed that the tip of the waveguide was broken off. The broken piece was returned. The reported condition was confirmed. 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, and the missing piece was returned. 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, retra ctors, etc. During use. The broken piece was returned. 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 instruction 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
[132547858]
According to the reporter, during the prostatectomy, the device was breaking the active tip of the clamp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2015-00854 |
| MDR Report Key | 5254269 |
| Date Received | 2015-11-30 |
| Date of Report | 2018-11-26 |
| Date of Event | 2015-11-09 |
| Date Mfgr Received | 2015-11-18 |
| Device Manufacturer Date | 2014-11-26 |
| Date Added to Maude | 2015-11-30 |
| 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 | LISA HERNANDEZ |
| 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 | 0 |
| Brand Name | ULTRASONIC DISSECTOR |
| Generic Name | ULTRASONIC DISSECTOR |
| Product Code | BWA |
| Date Received | 2015-11-30 |
| Returned To Mfg | 2018-10-30 |
| Model Number | SCD396 |
| Catalog Number | SCD396 |
| Lot Number | 43150137X |
| Device Expiration Date | 2019-11-30 |
| 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 | 2015-11-30 |