MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SONICISION; INSTRUMENT, ULTRASONIC SURGICAL

Model Number SCD391

Device Problems Failure to Deliver Energy (1211); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, intra-operatively, the device did not coagulate and the prongs are difficult to open at times.There was no patient injury.

Manufacturer Narrative

Additional information: b5, g4 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, intra-operatively, the device did not coagulate and the prongs are difficult to open at times.They used another like device and it worked fine.The device did not locked on any tissue.There was no patient injury.

Manufacturer Narrative

H3 evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found no defects.The reported condition was confirmed.Functional testing was performed with the returned dissector using a test lab generator and battery.The device was activated with the jaws closed and submerged in glycerin bath at both power modes with unacceptable results at certain angles of rotation of the waveguide.The failure is consistent with the audio speaker coming loose out of its housing because the speaker was not pushed deep enough into the housing receptacle after the adhesive application.Activating the device with the jaws closed causes the compression spring to come into contact with bare speaker leads resulting in a short.The device will not work in this state.The audio speaker came loose because the speaker was not pushed deep enough into the receptacle after the adhesive application.The audio speaker most likely came loose out of its housing during shipping or device use.Engineering was able to confirm the speaker had peeled away from the handle body and was likely contacting the bobbin assembly causing it to short.The adhesive tape was investigated; there appeared to be adhesive remaining on the tape.The speaker was fully pressed into the housing and it had adequate adhesion.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.

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.

• 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 Key: 9189320
• MDR Text Key: 162640821
• Report Number: 1717344-2019-01334
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10884521052659
• UDI-Public: 10884521052659
• Combination Product (y/n): N
• PMA/PMN Number: K101797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/04/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: SCD391
• Device Catalogue Number: SCD391
• Device Lot Number: 91180261X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 10/08/2019; 01/15/2020; 02/03/2020
• Supplement Dates FDA Received: 10/25/2019; 01/17/2020; 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1