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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO CLIP III; CLIP, IMPLANTABLE

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DAVIS & GECK CARIBE LTD ENDO CLIP III; CLIP, IMPLANTABLE Back to Search Results
Model Number 176630
Device Problems Display or Visual Feedback Problem (1184); Difficult to Open or Close (2921)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 12/23/2019
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 a laparoscopic colectomy, the counter did not turn on and the tip did not open.The procedure was completed with another device.
 
Manufacturer Narrative
Additional info: b5, d4, g4, h4, h6(fdp) 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 a laparoscopic colectomy, the counter did not turn on and the jaws did not open.The procedure was completed with another device.There was no patient injury.
 
Manufacturer Narrative
H3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received with fifteen clips remaining.Functional testing found the instrument to cycle without binding.Clips loaded into the jaws and formed properly.The clip counter was no longer active upon receipt of the instrument.The handle was disassembled for visualization of internal components.Upon inspection of the counter housing, it was noted particulates were present within the counter contact area, preventing activation.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The reported condition of jaws will not open was not confirmed.However, a manufacturing fault with the digital readout was identified during product analysis.The root cause of the observed condition was determined to be a result of particulate matter.This was identified as a quality issue with a component obtained from a third party supplier.A process improvement has been initiated to prevent this condition from recurring.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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
ENDO CLIP III
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key9552885
MDR Text Key179297041
Report Number9612501-2020-00055
Device Sequence Number1
Product Code FZP
UDI-Device Identifier10884521057852
UDI-Public10884521057852
Combination Product (y/n)N
PMA/PMN Number
K100242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 03/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Model Number176630
Device Catalogue Number176630
Device Lot NumberJ9G1200Y
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2020
Date Manufacturer Received03/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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