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

Model Number 72203012-

Device Problems Misfire (2532); Mechanics Altered (2984)

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

Event Date 08/01/2017

Event Type  malfunction  

Event Description

According to the reporter, during a gynecology procedure, as the device was resecting submucosal fibroid, the device stopped working.In order to resolve the issue, it was removed from hand piece slough chamber, re-clicked into place, and was placed back into the hand piece.It started resecting and shortly after, stopped working.No patient injury.

Manufacturer Narrative

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

Event Description

According to the reporter, per additional information received during a hysteroscopic myomectomy procedure, as the device was resecting submucosal fibroid, the device stopped working.Another device was used to resolve the issue.

• 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6830099
• MDR Text Key: 83963682
• Report Number: 1643264-2017-21077
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

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: 72203012-
• Device Catalogue Number: 72203012-
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 09/05/2017
• Supplement Dates FDA Received: 09/12/2017
• 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
• Patient Age: 52 YR
• Patient Weight: 91