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

Model Number 7209208

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the unit¿s part that was connected to the ic was internally damaged prior to use.There was no patient involvement.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection was performed and showed distal deposits on the cover glass and scratched, illumination fibers at distal tip needs to be polished, cosmetic refurbishing of the scope, optical system is loose, and glass particles in the optical system.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released 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.The instructions for use recommends ¿¿ careful inspection of the operative control unit before and after the procedure for possible signs of damage.Immediate detection and repair of minor damage will extend the life of the operative control unit.¿ 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 ACCESSORIES
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• Manufacturer (Section G): MITG-OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7123071
• MDR Text Key: 95202988
• Report Number: 1643264-2017-21144
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521746664
• UDI-Public: 10884521746664
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: 7209208
• Device Catalogue Number: 7209208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 01/25/2018
• 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