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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS SITUATE; COUNTER, SPONGE, SURGICAL
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MITG - RF SURGICAL SYSTEMS SITUATE; COUNTER, SPONGE, SURGICAL Back to Search Results
Model Number 01-0046
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, post-operatively, the device was not working when connected.The wand was not detecting even present.Replaced with another similar device and it worked fine.There was no patient involvement.
 
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Brand Name
SITUATE
Type of Device
COUNTER, SPONGE, SURGICAL
Manufacturer (Section D)
MITG - RF SURGICAL SYSTEMS
2101 faraday
carlsbad CA 92008
Manufacturer (Section G)
MITG - RF SURGICAL SYSTEMS
2101 faraday
carlsbad CA 92008
Manufacturer Contact
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12813613
MDR Text Key281931452
Report Number3005883396-2021-00030
Device Sequence Number1
Product Code LWH
UDI-Device Identifier10884521700727
UDI-Public10884521700727
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/15/2021
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 Number01-0046
Device Catalogue Number01-0046
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2021
Initial Date FDA Received11/15/2021
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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