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

Model Number 7209808S

Device Problems Break (1069); Mechanics Altered (2984)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during testing, the device would not work and hand piece was broken.There was no patient involvement.

Manufacturer Narrative

Evaluation summary received one (1) device.The returned sample did not meet specification as received.A visual inspection was performed on the exte rior of product and no physical damage was observed.The reported condition was confirmed.It appears that extreme force was used to remove multi-dwelling unit (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 investigation isolated the failure to the receptacle, but a root cause was not identified.If information is provided in the future, a supplemental report will be issued.

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 OK 73107
• Manufacturer (Section G): MITG-OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 7479941
• MDR Text Key: 107195906
• Report Number: 1643264-2018-02043
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521749917
• UDI-Public: 10884521749917
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 10/05/2018

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: 7209808S
• Device Catalogue Number: 7209808S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 07/03/2018; 08/08/2018
• Supplement Dates FDA Received: 07/18/2018; 10/05/2018
• 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