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

Model Number SCD391

Device Problems Crack (1135); Failure to Power Up (1476); Failure to Fire (2610)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

One device cordless ultrasonic dissector was returned for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection of the disposable device revealed that the dissector had a cracked waveguide.The waveguide broke off during product evaluation.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 indicated that the device was not functional.The waveguide was inspected under magnification and the origin of the cracks was identified.Investigation personnel concluded that the titanium waveguide was in use when it cracked and may have come in contact with any of the following; hemostats, clips, staples, retractors, etc.During use.Device use after damage can cause the cracked waveguide to 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.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.Instructions for 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 a procedure, the device did not activate.There was no patient injury.Initial investigation found out visual inspection of the disposable device revealed that the dissector had a cracked waveguide.The waveguide broke off during product evaluation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7732947
• MDR Text Key: 115587821
• Report Number: 1717344-2018-01000
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10884521052659
• UDI-Public: 10884521052659
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K101797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCD391
• Device Catalogue Number: SCD391
• Device Lot Number: 63200204X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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