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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MITG - OKLAHOMA CITY TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)
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MITG - OKLAHOMA CITY TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number 7209807S
Medical Device Problem Code Connection Problem (2900)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned sample did not meet specification as received.External inspection verified damage, and also found plastic missing from the tip of the fischer connector.The investigation could not determine a root cause or a probable root cause for the damage.The unit serial number is below rohs cutoff, and will be scrapped.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the port where tubing attaches has detached.
 
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Brand Name
TRUCLEAR
Common Device Name
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
MITG - OKLAHOMA CITY
75 s. meridian ave
oklahoma city OK 73107
MDR Report Key8457215
Report Number1643264-2019-20004
Device Sequence Number18939904
Product Code HIH
UDI-Device Identifier10884521749900
UDI-Public10884521749900
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K132015
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 03/27/2019
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 Number7209807S
Device Catalogue Number7209807S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/05/2019
Initial Report FDA Received Date03/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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