MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SONICISION; INSTRUMENT, ULTRASONIC SURGICAL

Model Number SCD396

Device Problems Material Fragmentation (1261); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

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 waveguide fracture occurs only in the activated state.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, and the missing piece was not 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, 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.

Event Description

According to the reporter, during the procedure, the first dissector did not activate and waveguide was broken off.The broken piece fell into patient's cavity, but all retrieved.Changed battery and generator and the problem persist.Replaced with similar dissector and it worked fine until 40 minutes of the procedure, the blade broke and fell into patient's abdominal cavity.The broken piece was retrieved by the surgeon.A device handpiece was used to complete the procedure.There was no patient injury.

• Brand Name: SONICISION
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 8503679
• MDR Text Key: 141593774
• Report Number: 1717344-2019-00484
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20884521052663
• UDI-Public: 20884521052663
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K101797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2022
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 72990257X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 70