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

Model Number 7209807-

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/18/2017

Event Type  malfunction  

Event Description

According to the reporter: occurred during testing.The tip broke off the control.No patient involved.

Manufacturer Narrative

Investigation summary post market vigilance (pmv) led an evaluation of one device.A visual inspection was performed on the product and aspiration spigot is broken off.Complaint of broken spigot was confirmed.Spigot has never been replaced and is over 4 years old.Other than the damage to spigot the mdu passes functional testing including high speed testing with blade installed.Unit passed functional tests on a known good control unit with footswitch.The complaint investigation has concluded that this unit has succumbed to damage to spigot.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer's quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Our instructions for use warn against the action that was taken.The ifu recommends ¿¿ careful inspection of the operative headpiece before and after the procedure for possible signs of damage.Immediate detection and repair of minor damage will extend the life of the operative headpiece.¿ damage may occur if the headpiece is handled roughly during use.Excessive forces may result in traumatic insertion, chipping particles of the optical glass, or other damage to the 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. 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 ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6866077
• MDR Text Key: 86259943
• Report Number: 1643264-2017-21086
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• 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