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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MITG-OKLAHOMA CITY HYSTEROSCOPIC FLUID MANAGEMENT; INSUFFLATOR, HYSTEROSCOPIC

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MITG-OKLAHOMA CITY HYSTEROSCOPIC FLUID MANAGEMENT; INSUFFLATOR, HYSTEROSCOPIC Back to Search Results
Model Number 7210165
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/21/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the unit's system failed during use.Fluid absorption was detected during the procedure.The fluid deficit went up to 3000 but then was manually evaluated and calculated by the nursing staff.The patient was held in pacu (post anesthesia care unit) for observation with fluid absorption.There was an extension of hospital stay by 23 hour observation.There was no patient injury.Patient status : unknown.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device no visual issue was observed.The subject unit presented an e02 error code when turned on.The subject unit was recalibrated, checked and passed all weights test.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
HYSTEROSCOPIC FLUID MANAGEMENT
Type of Device
INSUFFLATOR, HYSTEROSCOPIC
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 Key6999767
MDR Text Key91212545
Report Number1643264-2017-21128
Device Sequence Number1
Product Code HIG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/01/2018
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 Number7210165
Device Catalogue Number7210165
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/06/2017
Initial Date FDA Received11/03/2017
Supplement Dates Manufacturer Received01/24/2018
Supplement Dates FDA Received02/02/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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