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

Model Number	72203012
Medical Device Problem Codes	Bent (1059); Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, the device broke while resecting a 4cm submucous fibroid.The device started jamming up and then it appeared that the reciprocating blade was no longer completely within the shaft.The instrument was removed from the patient and inspected and appeared bent.They used a second device and during the procedure noticed a small piece of metal inside the patient's uterine cavity.The surgeon manually rotated the broken device into an open position to use it for suction and placed it back through the hysteroscope and placed it directly over the metal fragment and turned on the handpiece suction to get it out of the cavity.There was no patient injury.

• Brand Name: TRUCLEAR
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; street 1 : 75 s. meridian ave; oklahoma OK 73107
• MDR Report Key: 7428972
• Report Number: 1643264-2018-02038
• Device Sequence Number: 1718251
• Product Code: HIH
• UDI-Device Identifier: 00885554027617
• UDI-Public: 00885554027617
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K130215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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
• Operator of Device: Health Professional
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Device Lot Number: G47493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1