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

Model Number 7209808-

Device Problems Difficult to Insert (1316); Mechanical Jam (2983)

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

Event Date 05/16/2017

Event Type  malfunction  

Event Description

According to the reporter, during device testing, the unit was jammed and something seems to stuck inside connection port.There was no patient involvement noted.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Complaint of broken piece from mdu stuck in control unit's receptacle was confirmed.It appears that extreme force was used to remove mdu connector on power cord from hand piece receptacle on control unit which caused shaft to break off mdu connector and become stuck inside of hand piece receptacle.The complaint investigation has concluded that this is a user error since product has been in use at customer site for almost 3 years before incident occurred.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; therefore, a device history record will not be performed.The root cause of the observed condition was determined to be a result of a misuse of the product.The ifu recommends ¿¿ careful inspection of the operative hysteroscope before and after the procedure for possible signs of damage.Immediate detection and repair of minor damage will extend the life of the operative hysteroscope.¿ damage may occur if the user attempts to connect a damaged or defective hand piece to the control unit.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
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 75 s. meridianave; oklahoma OK 73107
• Manufacturer (Section G): MITG-OKLAHOMA CITY; 75 s. meridianave; oklahoma OK 73107
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6641151
• MDR Text Key: 77610422
• Report Number: 1643264-2017-21046
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

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: 7209808-
• Device Catalogue Number: 7209808-
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 11/03/2017
• Supplement Dates FDA Received: 12/01/2017
• 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