MAUDE Adverse Event Report: MITG-OKLAHOMA CITY TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 7209807

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, prior to use, the back of the shaver handpiece that collects tissue came off.There was no patient involvement.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 75 s. meridian ave; oklahoma city OK 73107
• Manufacturer (Section G): MITG-OKLAHOMA CITY; 75 s. meridian ave; oklahoma city OK 73107
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 9195060
• MDR Text Key: 163050956
• Report Number: 1643264-2019-20021
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521749924
• UDI-Public: 10884521749924
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7209807
• Device Catalogue Number: 7209807
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2019
• 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