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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SONICISION; INSTRUMENT, ULTRASONIC SURGICAL
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COVIDIEN MFG DC BOULDER SONICISION; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Model Number SCD396
Device Problems Material Fragmentation (1261); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2019
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 the surgery, the dissector began to make a noise and it was verified that the tip of the clamp broke.The tip fell into the patient's cavity, but was soon withdrawn.The device was used without intercurrence.No patient harm.
 
Event Description
According to the reporter, during the endometriosis surgery, the dissector began to make a noise and it was verified that the tip of the clamp broke.The tip fell into the patient's cavity, but was soon withdrawn using a video laparoscope screw.The device was used without intercurrences.There was no patient injury.
 
Manufacturer Narrative
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.
 
Event Description
According to the reporter, during the endometriosis surgery, the dissector began to make a noise and it was verified that the tip of the clamp broke.The tip fell into the patient's cavity, but was soon withdrawn using a video laparoscope screw.The device was used without intercurrences.No patient harm.
 
Manufacturer Narrative
Evaluation summary: one device was returned for evaluation.The returned product did not meet specification as received.Visual inspection of the disposable device revealed that the tip of the waveguide was broken off.The broken piece was not returned.The reported condition was confirmed.Investigation personnel performed functional testing on the returned hand piece using a test lab generator and battery.The assembled device returned a green light and a welcome tone, but immediately returned a red light emitting diode (led) indicator with an error tone (alarm activation) when the device was activated.This characteristic indicated that the device was not functional.The waveguide had its tip missing.Investigation personnel concluded that the titanium waveguide was in use when it cracked and broke off, and may have come in contact with any of the following; hemostats, clips, staples, retractors, etc.During use.The investigation identified the cause of the reported event to be user error.The device instructions for use currently contain a warning again st contact between the dissector tip and metal objects (hemostats, clips, staples, retractors, etc.) during activation.Contact with metal objects during use will cause the active blade to crack and may eventually break off.This issue is specific to ultrasonic dissectors.The instructions for use (ifu) advises device users to visually inspect all system components for breaks, cracks, nicks, or other damages prior to use.Ifu also states: do not use damaged components.Use of damaged components may result in injury to the patient or user.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
SONICISION
Type of Device
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
MDR Report Key8546167
MDR Text Key143667960
Report Number1717344-2019-00554
Device Sequence Number1
Product Code LFL
UDI-Device Identifier20884521052663
UDI-Public20884521052663
Combination Product (y/n)N
PMA/PMN Number
K101797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/06/2023
Device Model NumberSCD396
Device Catalogue NumberSCD396
Device Lot Number81520238X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2019
Date Manufacturer Received07/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age36 YR
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