MAUDE Adverse Event Report: MITG-OKLAHOMA CITY TRUCLEAR; INSUFFLATOR, HYSTEROSCOPIC

Model Number 7210165-

Device Problem Break (1069)

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

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during set up last (b)(6), the device had scratch on the lens.There was no patient involvement.

Manufacturer Narrative

Evaluation 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 (100-2500 rpms) 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 quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.The root cause of the observed condition was determined to be a result of a misuse of the product.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: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 75 s. meridianave; oklahoma OK
• Manufacturer (Section G): MITG-OKLAHOMA CITY; 75 s. meridianave; oklahoma OK
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6871921
• MDR Text Key: 86454545
• Report Number: 1643264-2017-21090
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• 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: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210165-
• Device Catalogue Number: 7210165-
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2017
• 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