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

Model Number 72203012

Device Problems Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, the product did not perform its reciprocating function to be able to make a recession of the intra-uterine myoma.No other instrument was use and the product was removed from the hand piece.The case was aborted, and was rescheduled on (b)(6) 2020.

• 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: 10696888
• MDR Text Key: 211875268
• Report Number: 1282497-2020-00042
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 00885554027617
• UDI-Public: 00885554027617
• Combination Product (y/n): N
• Reporter Country Code: RQ
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2020
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Device Lot Number: 4067716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/19/2020
• Date Device Manufactured: 12/20/2017
• 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: 40 YR