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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

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COVIDIEN LP - SUPERDIMENSION INC EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number SD303BA
Device Problems Application Program Problem (2880); Component or Accessory Incompatibility (2897)
Patient Problem No Code Available (3191)
Event Date 03/10/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during the procedure, the surgeon was unable to pass the cable thru port.The procedure was not completed.
 
Manufacturer Narrative
Additional information: d10, g4, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was returned for evaluation.Functional testing found no problem with the device.It was reported that the surgeon was unable to pass the cable thru port.A related device issue could not be confirmed.A potential root cause for the issue could not be identified, because no issue was detected with the device.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that products meet all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
EDGE
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
COVIDIEN LP - SUPERDIMENSION INC
161 cheshire lane, suite 100
plymouth MN 55441
MDR Report Key10058246
MDR Text Key195245615
Report Number3004962788-2020-00030
Device Sequence Number1
Product Code JAK
UDI-Device Identifier10884521199545
UDI-Public10884521199545
Combination Product (y/n)N
PMA/PMN Number
K151376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/02/2022
Device Model NumberSD303BA
Device Catalogue NumberSD303BA
Device Lot Number512902
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2020
Initial Date Manufacturer Received 04/29/2020
Initial Date FDA Received05/14/2020
Supplement Dates Manufacturer Received06/08/2020
Supplement Dates FDA Received06/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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