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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MITG-OKLAHOMA CITY TRUCLEAR SHEATH; HYSTEROSCOPE (AND ACCESSORIES)
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MITG-OKLAHOMA CITY TRUCLEAR SHEATH; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number 72204753
Device Problems Bent (1059); Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during the cleaning process, two same devices were damaged.The sheaths were both bent and one was broken in half when someone tried to straighten it.There was no patient involvement.
 
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Brand Name
TRUCLEAR SHEATH
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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6984565
MDR Text Key90951493
Report Number1643264-2017-21124
Device Sequence Number1
Product Code HIH
UDI-Device Identifier00885556583685
UDI-Public00885556583685
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152143
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/27/2017
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 Number72204753
Device Catalogue Number72204753
Device Lot Number1444615
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/04/2017
Initial Date FDA Received10/27/2017
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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