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

Model Number	SCD48
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: one device 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 piece was not 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 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 eventually break off.The investigation identified the root 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 instructions for use (ifu) notes that device users should 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.No update to the risk management file is required at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the hand piece was being used and stopped working during case, giving red indication.The battery and generator was exchanged with no improvement.The hand piece was replaced and worked properly with original battery/generator.There was no patient injury.

• 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: 7885401
• Report Number: 1717344-2018-01238
• Device Sequence Number: 2725954
• Product Code: LFL
• UDI-Device Identifier: 10884521195226
• UDI-Public: 10884521195226
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2023
• Device Model Number: SCD48
• Device Catalogue Number: SCD48
• Device Lot Number: 81240144X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR