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

Model Number	SCG7AB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Burn(s) (1757); Hematuria (2558); Dysuria (2684); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, post laparoscopic oophorectomy with salpingectomy, the patient had a 2cm burn defect in bladder and it was repaired.During the operation, cystoscopy was performed and blood was seen in foley catheter.Foley catheter was removed and spontaneously voided prior to discharge.Urine output was 1500cc overnight and minimal blood was noted.Creatinine was 0.7 and stable.On the next day, the patient reported decreased urine output, abdominal pain, swelling and dysuria.The patient had prolonged hospitalization.Foley catheter was placed during in-office visit and 500cc output immediately on placement.Foley catheter remained for few days.
Additional Manufacturer Narrative
D10 concomitant products: scd7a39 - sonicision 7 dissector scd7a39 39 cm, lot# unknown scba - battery scba, serial# 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.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.
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 laparoscopic oophorectomy with salpingectomy, the patient had a 2cm burn defect in bladder and it was repaired.During the operation, cystoscopy was performed and blood was seen in foley catheter.Foley catheter was removed and spontaneously voided prior to discharge.Urine output was 1500cc overnight and minimal blood was noted.Creatinine was 0.7 and stable.On the next day, the patient reported decreased urine output, abdominal pain, swelling and dysuria.The patient had prolonged hospitalization.Foley catheter was placed during in-office visit and 500cc output immediately on placement.Foley catheter remained for few days.Foley catheter was removed.Urine specimen was collected for culture and sensitivity.Patient was well.
Event or Problem Description
According to the reporter, post laparoscopic oophorectomy with salpingectomy, the patient had a 2cm burn defect in bladder and it was repaired.During the operation, cystoscopy was performed and blood was seen in foley catheter.Foley catheter was removed and spontaneously voided prior to discharge.Urine output was 1500cc overnight and minimal blood was noted.Creatinine was 0.7 and stable.On the next day, the patient reported decreased urine output, abdominal pain, swelling and dysuria.Patient had prolonged hospitalization.Foley catheter was placed during in-office visit and 500cc output immediately on placement.Foley catheter remained for few days.Foley catheter was removed.Urine specimen was collected for culture and sensitivity.Extensive vesicouterine fibrosis was present prior to surgery and hole in the bladder was a result of the abnormal anatomy and not caused by instrument.Patient is well.
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.
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, during laparoscopic oophorectomy with salpingectomy, the patient had a 2cm burn defect in bladder and it was repaired.During the operation, cystoscopy was performed and blood was seen in foley catheter.Foley catheter was removed and spontaneously voided prior to discharge.Urine output was 1500cc overnight and minimal blood was noted.Creatinine was 0.7 and stable.On the next day, the patient reported decreased urine output, abdominal pain, swelling and dysuria.Patient had prolonged hospitalization.Foley catheter was placed during in-office visit and 500cc output immediately on placement.Foley catheter remained for few days.Foley catheter was removed.Urine specimen was collected for culture and sensitivity.Extensive vesicouterine fibrosis was present prior to surgery and hole in the bladder was a result of the abnormal anatomy and not caused by instrument.Patient is well.

• 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: 20493214
• Report Number: 1717344-2024-01995
• Device Sequence Number: 11814277
• Product Code: LFL
• UDI-Device Identifier: 10884521794825
• UDI-Public: 10884521794825
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K212301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/11/2025

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: SCG7AB
• Device Catalogue Number: SCG7AB
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 10/15/2024; 02/06/2025; 02/27/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 10/25/2024; 02/13/2025; 03/11/2025
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic
• Patient Race: White