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

Model Number UNKNOWN - TRUCLEAR

Device Problems Material Opacification (1426); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/15/2023

Event Type  Injury  

Event Description

According to the literature, a retrospective study analyzed the success percentage and complications in patients who underwent hysteroscopic resection of retained products of conception between (b)(6) 2017 and (b)(6) 2021.Truclear system 5.0 was used for the procedure.There were 76 patients in the study and hysteroscopy was unsuccessful in two patients due to bleeding and poor visibility with incomplete resection.Both patients required a modified procedure to complete the treatment.It is unclear if the modified procedure took place at time of initial procedure or at a later date.

Manufacturer Narrative

D10 concomitant product: unknown - truclear, unknown truclear device (serial#unknown) title: our experience in in-office hysteroscopic handling of debris ovulars with mechanical energy.Source: prog obstet ginecol 2023;66:256-262 | clàudia pérez carbonell, pere brescó i torras, jennifer rovira pampalona, oliveres amor, ángela zumelmarne, and maría degollada bastos | accepted: 15/12/2023.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.

Manufacturer Narrative

Additional information: g3 correction: h6 (changed to surgical intervention fdp, imf) 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: UNKNOWN TRUCLEAR DEVICE
• Type of Device: 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: 19117056
• MDR Text Key: 340288174
• Report Number: 1282497-2024-00045
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN - TRUCLEAR
• Device Catalogue Number: UNKNOWN - TRUCLEAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention