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

Model Number	SCDA48
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance led an investigation into the reported complaint in conjunction with engineering.One device was received for evaluation.The returned product did not meet specification as received.Visual inspection of the disposable device revealed that the dissector had a broken waveguide.The tip of the waveguide was not returned.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 led indicator with an error tone (alarm activation) when the device was activated, indicating that the device was not functional.The waveguide was missing its tip, and the tip was not returned.Further investigation revealed that the waveguide was excessively torqued to the side during use, causing it to come in contact with the clamping jaw and weakening the waveguide.Continued use then caused a crack to propagate until the material failed.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic longitudinal gastrectomy, the hand piece stopped working and alarmed with red light after they used for about 30 seconds.Scrub check did check hand piece before using and with no issue.Alarmed after trying to cut tissue.Multiple charged batteries used and still did not work.Opened and used new hand piece and it worked.The initial visual inspection of the disposable device revealed that the dissector had a broken waveguide.The tip of the waveguide was not returned.
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 longitudinal gastrectomy , the hand piece stopped working and alarmed with red light after they used for about 30 seconds.Scrub check did check hand piece before using and with no issue.Alarmed after trying to cut tissue.Multiple charged batteries used and still did not work.Opened and used new hand piece and it worked.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: 9638974
• Report Number: 1717344-2020-00080
• Device Sequence Number: 10867256
• Product Code: LFL
• UDI-Device Identifier: 10884521592858
• UDI-Public: 10884521592858
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 06/13/2024
• Device Model Number: SCDA48
• Device Catalogue Number: SCDA48
• Device Lot Number: 91570045X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/25/2020
• 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: 63 YR