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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER HYSTEROSCOPE; HYSTEROSCOPE (AND ACCESSORIES)

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COVIDIEN MFG DC BOULDER HYSTEROSCOPE; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number 72205001
Device Problem Incorrect Measurement (1383)
Patient Problem No Patient Involvement (2645)
Event Date 01/22/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, prior to use, the unit readings were way off right out of the box.There was no patient involvement.
 
Manufacturer Narrative
This event has been reassessed and found not to be a reportable event and is not associated with a serious injury or potential for serious injury with reoccurrence.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
HYSTEROSCOPE
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
Manufacturer (Section G)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
Manufacturer Contact
lisa hernandez
5920 longbow drive
boulder, CO 80301
2034925563
MDR Report Key9664823
MDR Text Key177824763
Report Number1717344-2020-00114
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/11/2020
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
Device Operator Health Professional
Device Model Number72205001
Device Catalogue Number72205001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/22/2020
Initial Date FDA Received02/04/2020
Supplement Dates Manufacturer Received01/22/2020
Supplement Dates FDA Received02/11/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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