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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)
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COVIDIEN TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number 72202536
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2020
Event Type  malfunction  
Event Description
After introducing the shaver into the cervix, uterus, a small piece of blue plastic was seen floating in the uterus.The equipment in question was the 4 mm tru clear covidien soft tissue shaver that was inserted by md to perform polypectomy.Md noticed a small blue foreign body in uterus that seemed consistent with a part of the shaver end.Md immediately suctioned the foreign body, removed the shaver from patient and from sterile field.Another device was obtained.Md finished the endometrial polyp removal and an endometrial curettage was performed.One last look was made of uterus and no other foreign bodies were noted.
 
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Brand Name
TRUCLEAR
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN
12 gill street, suite 3500
woburn MA 01801
MDR Report Key9910148
MDR Text Key185943184
Report Number9910148
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number72202536
Device Catalogue Number72202536
Device Lot Number4946173
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/04/2020
Event Location Hospital
Date Report to Manufacturer04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age16425 DA
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