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

Model Number	SCD48
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Exsanguination (1841); Blood Loss (2597)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operatively, sleeve gastrectomy was performed and no active bleeding was witnessed at the time of closing.Three hours later, the patient had to be re-operated on due to excessive bleeding.Seventeen-hundred (1700) cc were lost and the patient was given three units of blood.No active bleeding was witnessed during reoperation but it was suspected that the bleeding came from the mesentery of the stomach.The patient¿s hospitalization was extended for two days.

• 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: 7666444
• Report Number: 1717344-2018-00904
• Device Sequence Number: 1050426
• 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): 07/06/2018

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 Model Number: SCD48
• Device Catalogue Number: SCD48
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/06/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR