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

Model Number 72202536

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

Title: hysteroscopy in removing retained products of conception ¿ a highly successful approach with minimal complications source: journal of obstetrics and gynaecology 2020, vol.40, no.8, 1122¿1126 https://doi.Org/10.1080/01443615.2019.1679736.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a study analyzed 101 patients with retained products of conception who underwent office hysteroscopy from 2012 to 2015.The truclear 5.0 system, 5.5mm oval hysteroscope and 5.0 mm hysteroscopic morcellator were used.The 5.0 mm hysteroscopic morcellator was used in 7 patients.Complications were mild to moderate bleeding requiring uterotonics or resulting in inability to complete procedure, infection (endometritis) requiring iv antibiotics.

• Brand Name: TRUCLEAR
• 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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 11301865
• MDR Text Key: 230977028
• Report Number: 1282497-2021-00012
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521744080
• UDI-Public: 10884521744080
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,user facil
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202536
• Device Catalogue Number: 72202536
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR