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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 UNKNOWN TRUCLEAR DEVICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Perforation (2001)
Event Type  Injury  
Manufacturer Narrative
Title: an alternative approach for removal of placental remnants: hysteroscopic morcellation source: journal of minimally invasive gynecology, vol.20, article no.6, (796-802),(november/december 2013, date of publication: 24-apr-2013.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during hysteroscopic morcellation was used for removal of placental remains.Analysis of 105 procedures was performed.Perforation (access related) 4 (3.8%), fever 3 (2.9%), perforation, hysteroscopy related 2 (1.9%), incomplete removal (fluid deficit greater than or equal to 2500 ml) 2 (1.9%), incomplete removal at follow up 2 (1.9%), hemorrhage 1 (1%) and abdominal pain 1 (1%).
 
Manufacturer Narrative
Evaluation summary: this report is based on information provided by the post market vigilance (pmv) team.The product sample was not returned to the post market vigilance laboratory; however, a picture was provided by the customer for analysis.The information provided does not indicate if the device met specification.The reported condition was not confirmed due to inadequate sample.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.If additional information is obtained, or the sample is returned to investigation team, we will re-open this investigation.If information is provided in the future, a supplemental report will be issued.
 
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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 Key7834202
MDR Text Key118806052
Report Number1643264-2018-02059
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN TRUCLEAR DEVICE
Device Catalogue NumberUNKNOWN TRUCLEAR DEVICE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/13/2018
Initial Date FDA Received08/30/2018
Supplement Dates Manufacturer Received10/31/2018
Supplement Dates FDA Received11/29/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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