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

Model Number	7209807
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/09/2018
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 testing, the device¿s plug was broken.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one device sample was received for evaluation.This device has been used in the treatment or diagnosis of a patient.The returned sample did not meet specification as received by manufacturer.A visual inspection was performed on the product and damage was observed to the power cord connector.The reported condition was confirmed.The investigation found that the plastic tube covering the connector pins on the power cord assembly has been broken off the connector.It appears that the excessive force was used to remove the cable connector from the control unit receptacle possibly at a slight angle, thus breaking off the plastic tube.The investigation isolated the additional failure to the damage cord connector, but a root cause was not identified.No update to the risk management file is required at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR HANDPIECE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• MDR Report Key: 7518634
• Report Number: 1643264-2018-02048
• Device Sequence Number: 13877151
• Product Code: HIH
• UDI-Device Identifier: 10884521749924
• UDI-Public: 10884521749924
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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: 7209807
• Device Catalogue Number: 7209807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1