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

Model Number	SCD48
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation: the incident sample was requested but to date has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the device stopped working during a procedure.The doctor removed the device from the trocar and the jaw fell off the device when it was outside the patient.The broken jaw was taped to the device for return.There was no patient injury.
Additional Manufacturer Narrative
Correction: evaluation summary: one sonicision cordless ultrasonic dissector was returned for evaluation.The returned product did not meet specification as received.Visual inspection of the disposable hand piece revealed that the waveguide had fractured and the tip had broken off.The broken tip was returned with the device.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.The ifu also advices 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.

• Brand Name: SONICISION
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7005098
• Report Number: 1717344-2017-06176
• Device Sequence Number: 944002
• Product Code: LFL
• UDI-Device Identifier: 20884521195223
• UDI-Public: 20884521195223
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: SCD48
• Device Catalogue Number: SCD48
• Device Lot Number: 72140235X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 12/02/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR