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

Model Number SCD396

Device Problems Break (1069); Failure to Cut (2587); Intermittent Energy Output (4025)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: two sonicision cordless ultrasonic dissector were returned for evaluation.These devices have been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the products were within the assigned expiration date at the time of the reported incident.The returned products did not meet specification as received.Visual inspection of the disposable devices revealed that the tips of each of the waveguides were broken off.The broken pieces were not returned.The customer reported the device stopped working.The reported condition was confirmed.Investigation personnel performed functional testing on the returned hand pieces using a test lab generator and battery.The assembled devices returned a green light and a welcome tone, but immediately returned a red led indicator with an error tone (alarm activation) when the device was activated.This characteristic indicated that the device was not functional.The waveguides had its tip missing, and the missing pieces were not returned.Investigation personnel concluded that one of 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.Investigation personnel concluded that the other titanium waveguide was also in use when it fractured.Further investigation revealed that the waveguide was excessively torqued to the side during use causing it to come in contact with the moving jaw of the device while it was being activated.This contact caused the waveguide to crack and break off.The investigation identified the cause of the reported event to be user error.The device instructions for use (ifu) 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 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.The failure identified is captured in the current risk management documents.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic procedure, the sonicision dissector stopped working.Another battery was installed and an error tone and a red light were observed.Two scd396 dissectors were returned and initial evaluation of the returned devices found that the waveguides were broken off of the devices.The broken pieces were not returned with the devices.

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: 7682080
• MDR Text Key: 113788368
• Report Number: 1717344-2018-00922
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20884521052663
• UDI-Public: 20884521052663
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K101797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 60420099X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2016
• 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 Outcome(s): Other