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

Model Number	SCD48
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic roux en y gastric bypass, the dissector blade broke after being removed from the patient.The generator alarmed and the red light indicator illuminated.The device was removed from patient to be wiped clean but when the dissector was pulled from applied trocar the blade broke outside of the patient and fell on the floor.New device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was returned for evaluation.Visual inspection of the disposable device revealed that the tip of the waveguide was broken off.The reported condition was confirmed.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, indicating the device was not functional.The investigation concluded that the titanium waveguide fractured from continued use after becoming damaged, 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 instructions for use(ifu) warns: contact between the active blade and other metal objects (hemostats, clips, staples, retractors, etc.) may result in product damage, such as a broken blade.Pieces of a broken blade may fall into the surgical cavity causing unintended tissue damage.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 8250593
• Report Number: 1717344-2019-00093
• Device Sequence Number: 1929350
• Product Code: LFL
• UDI-Device Identifier: 10884521195226
• UDI-Public: 10884521195226
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 03/07/2019

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: 08/02/2023
• Device Model Number: SCD48
• Device Catalogue Number: SCD48
• Device Lot Number: 82130224X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1