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

Model Number	SCGAA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Anemia (1706); Hematoma (1884); Nausea (1970); Pain (1994); Seroma (2069); Unintended Radiation Exposure (4565); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, post total laparoscopic bilateral salpingo-oophorectomy with sentinel node biopsy, the patient had an abdominal pain (icd10-cm r10.9) and presented for an abdominal hysterectomy.The patient was doing well postoperatively, then developed pain approximately 2 to 3 days after discharge that gradually got worse.The patient denied fevers.Stated that the patient had decreased appetite and nausea.The patient denied fever or purulent discharge.Patient undergone radiology exam with findings of favor abscess although seroma and walled off hematoma and large 10 cm lesion within the posterior right lobe of the liver.Interventional procedure performed such as flush drain with 10 cc of saline every 12hours, monitor output, follow up cultures and partial drainage of the fluid collection.Electrocardiogram (ecg) showed normal sinus rhythm, normal ecg.
Additional Manufacturer Narrative
D10 concomitant products: scd7a39, sonicision 7 dissector scd7a39 39 cm, (lot #unknown); scba, battery scba, (sn: unknown).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: b5, g3.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, post total laparoscopic bilateral salpingo-oophorectomy with sentinel node biopsy, the patient had an abdominal pain (icd10-cm r10.9) and presents for an abdominal hysterectomy.The patient was doing well postoperatively, then developed pain approximately 2 to 3 days after discharge that gradually got worse.The patient denies fevers or purulent discharge.Stated that the patient had decreased appetite and nausea.Patient undergone radiology exam with findings of favor abscess although seroma and walled off hematoma and large 10 cm lesion within the posterior right lobe of the liver.Interventional procedure performed such as flush drain with 10 cc of saline every 12 hours, monitor output, follow up cultures and partial drainage of the fluid collection.Intravenous (iv) antibiotics followed by oral antibiotics.Electrocardiogram (ecg) showed normal sinus rhythm, normal ecg.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, post total laparoscopic bilateral salpingo-oophorectomy with sentinel node biopsy, the patient had an abdominal pain (icd10-cm r10.9) and presents for an abdominal hysterectomy.The patient was doing well postoperatively, then developed pain approximately two to three days after discharge that gradually got worse.The patient denies fevers.Stated that the patient had decreased appetite and nausea.The patient denies fever or purulent discharge.Patient undergone radiology exam with findings of favor abscess although seroma and walled off hematoma and large 10 cm lesion within the posterior right lobe of the liver.Interventional procedure performed such as flush drain with 10 cc of saline every 12 hours, monitor output, follow up cultures and partial drainage of the fluid collection.Intravenous (iv) antibiotics followed by oral antibiotics.Electrocardiogram (ecg) showed normal sinus rhythm, normal ecg.The patient had postoperative abscess and anemia.

• Brand Name: SONICISION
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21028318
• Report Number: 1717344-2024-02266
• Device Sequence Number: 19835546
• Product Code: LFL
• UDI-Device Identifier: 10884521592865
• UDI-Public: 10884521592865
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K180149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: SCGAA
• Device Catalogue Number: SCGAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/09/2025; 02/14/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/17/2025; 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American