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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS UNKNOWN LAP SPONGE; ERYTHROCYTE SUSPENSION, MULTI SPECIES, SEROLOGICAL REAGENT AND EQUIPMENT
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MITG - RF SURGICAL SYSTEMS UNKNOWN LAP SPONGE; ERYTHROCYTE SUSPENSION, MULTI SPECIES, SEROLOGICAL REAGENT AND EQUIPMENT Back to Search Results
Model Number UNKNOWN LAP SPONGE
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a procedure, the sponges was falling apart.Pieces of the sponge are being found during the case in the patient and surgeons are having to pick out the "stringy" pieces.There was no patient injury.
 
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Brand Name
UNKNOWN LAP SPONGE
Type of Device
ERYTHROCYTE SUSPENSION, MULTI SPECIES, SEROLOGICAL REAGENT AND EQUIPMENT
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
lisa hernandez
5920 longbow drive
boulder, CO 80301
2034925563
MDR Report Key9960560
MDR Text Key191837556
Report Number3005883396-2020-00026
Device Sequence Number1
Product Code LHW
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN LAP SPONGE
Device Catalogue NumberUNKNOWN LAP SPONGE
Device Lot Number19L134862
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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