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

Model Number 7209807-

Device Problem Overheating of Device (1437)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

According to the reporter: during the procedure, the device became hot and showed signs of smoke.No patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The complaint investigation has concluded that this unit has succumbed to expected wear and tear.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR HANDPIECE
• 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: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6464483
• MDR Text Key: 71902417
• Report Number: 1643264-2017-21013
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-
• Device Lot Number: YE00592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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