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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT UNIVERSAL DUAL; MEGA SOFT UNIVERSAL DUAL
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MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT UNIVERSAL DUAL; MEGA SOFT UNIVERSAL DUAL Back to Search Results
Model Number 0846
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2020 attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event or Problem Description
It was reported that during an unknown procedure, the upper sheath of megasoft is torn and not working.There were no patient consequences.
 
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Brand Name
MEGASOFT UNIVERSAL DUAL
Common Device Name
MEGA SOFT UNIVERSAL DUAL
Manufacturer (Section D)
MEGADYNE MEDICAL PRODUCTS, INC.
11506 south state street
draper UT 84020
MDR Report Key11004353
Report Number1721194-2020-00068
Device Sequence Number3813755
Product Code GEI
UDI-Device Identifier10614559104248
UDI-Public10614559104248
Combination Product (Y/N)N
PMA/510(K) Number
K133726
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/30/2020
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
Operator of Device Health Professional
Device Model Number0846
Device Catalogue Number0846
Device Lot Number186868010
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/30/2020
Initial Report FDA Received Date12/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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