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

Model Number 7209807-

Device Problems Break (1069); Suction Problem (2170); Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2017

Event Type  malfunction  

Event Description

According to the reporter, during use of the device, the suction port was broken.No information has been noted for the patient status.

Event Description

According to the reporter, the suction port was physically broken off after surgery when disconnecting the suction tubing.It worked fine until that point.

• 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: 6578044
• MDR Text Key: 75535171
• Report Number: 1643264-2017-21030
• Device Sequence Number: 1
• Product Code: HIH
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

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-
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: 06/02/2017
• Supplement Dates FDA Received: 07/03/2017
• 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