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

Model Number 72202976

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of one device.A visual inspection was performed and showed severe distal tip damage, bent sheath, and the stopcock is damaged and leaky.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.The instruction for use (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 hysteroscope 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.

Event Description

According to the reporter during procedure, there was a black line on display.The unit was swapped.There was no harm.There was no patient involvement, injury, medical intervention, death, or labeling/packaging issues.

Manufacturer Narrative

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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7324212
• MDR Text Key: 101966451
• Report Number: 1643264-2018-02026
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

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: 72202976
• Device Catalogue Number: 72202976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 04/05/2018
• 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