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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUCLEAR HYSTEROSCOPE
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TRUCLEAR HYSTEROSCOPE Back to Search Results
Device Problem Problem with Sterilization (1596)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2022
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2022, the tray was opened in the operating room prior to a procedure.Upon opening the tray, the truclear scopes were found to be assembled.The scopes must be disassembled prior to sterilization.The discovery was made prior to the patient being brought into the operating room.Since tray was the only one available, the procedure had to be postponed until (b)(6) 2023.To ensure there are no reoccurrences, staff and quality staff were made aware that the truclear is supposed to be disassembled prior to sterilization.The decontamination technician was also made aware of this oversight.Count sheet and processing instructions are currently being updated to reference the need to disassemble truclear devices prior to sterilization.No additional issues have been reported.
 
Event Description
The user facility reported that truclear was sterilized assembled.Truclear device within tray should be disassembled before sterilization.Since this was the only tray available it resulted in the case being postponed.
 
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Brand Name
TRUCLEAR HYSTEROSCOPE
Type of Device
HYSTEROSCOPE
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key16134329
MDR Text Key308733518
Report Number1527821-2023-00001
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/12/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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