MAUDE Adverse Event Report: COVIDIEN MANSFIELD TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	72203012
Medical Device Problem Codes	Suction Problem (2170); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Edema (2020)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product: 72205000, control unit(b)(4) hysterolux.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 post operative hysteroscopic myomectomy, no product failure/issues and there were no issues with the hysterolux.Fluid deficit reading increased quickly throughout the procedure.Once deficit limit was reached, an abdominal ultrasound showed free fluid inside patient¿s abdomen.Final fluid deficit was recorded at 2520 cc of ns.Manual count was also performed to confirm correct fluid system reading.Fluid was suctioned off floor in the amount of ~280cc.Patient developed pulmonary edema into post anesthesia care unit.Bilevel positive airway pressure was performed and administration of furosemide.The entire hysteroscopy was approximately 10 minutes.Patient was said to be stable a few hours later.The event lead the patient to stay overnight in the hospital and was discharged the next day.
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 operative hysteroscopic myomectomy, no product failure/issues and there were no issues with the hysterolux during uterine fibroid removal.Pump has been zeroed after priming/during the procedure.The pressure used was 60 mmhg -100 mmhg.Three liters of fluid bag size was used.Normal saline was the distention medium used.Deficit limit was set to 2500cc.Fluid deficit reading increased quickly throughout the procedure.Once deficit limit was reached, an abdominal ultrasound showed free fluid inside patient¿s abdomen.Final fluid deficit was recorded at 2520cc of normal saline.Manual count was also performed to confirm correct fluid system reading and deficit reading.Fluid was suctioned off floor in the amount of ~280cc.The amount suctioned off the floor was subtracted from what the machine was reading.2800cc deficit value was displayed on the pump at the end of the procedure.No fluid has been left in the under-buttocks drapes.Patient developed pulmonary edema into post anesthesia care unit.Bilevel positive airway pressure was performed and administration of furosemide.The entire hysteroscopy was approximately 10 minutes.Patient was said to be stable a few hours later.The event lead the patient to stay overnight in the hospital and was discharged the next day.
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.

• Brand Name: TRUCLEAR
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19214943
• Report Number: 1282497-2024-00072
• Device Sequence Number: 12811664
• Product Code: HIH
• UDI-Device Identifier: 10884521744110
• UDI-Public: 10884521744110
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2024

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: 72203012
• Device Catalogue Number: 72203012
• Device Lot Number: 5654182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 05/28/2024; 05/31/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/04/2024; 06/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 56 KG