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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 Mechanical Problem (1384); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2020
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 procedure, the device was able to fire normally until the sixth firing, when the handle became stiff.On the seventh firing, additional force was applied to squeeze the handle, but the clip came out in a broken state.The clip fell into the patient's cavity and was retrieved.A new device was used to resolve the issue and complete the procedure.There was no patient injury.
 
Event Description
According to the reporter, during a laparoscopic cholecystectomy procedure, the device was able to fire normally until the sixth firing, when the handle became stiff.On the seventh firing , additional force was applied to squeezed the handle, but the clip came out in a broken state.The clip fell into the patient's cavity and was retrieved.A new device was used to resolve the issue and complete the procedure.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.
 
Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the instrument was partially applied.The clip counter was no longer active.A small metal component was received with the instrument, it appears to be from the driver.Functionally, the instrument was cycled to load a clip and a potion of the driver was missing.It was reported that the clips did not close completely and were malformed, a component disengaged from the device into the surgical cavity, and the handle was binding.The reported issue were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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 cholecystectomy procedure, the device was able to fire normally until the sixth firing, when the handle became stiff.On the seventh firing , additional force was applied to squeezed the handle, but the clip came out in a broken state.The clip fell into the patient's cavity and was retrieved.A new device was used to resolve the issue and complete the procedure.There was no patient injury.
 
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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 Key10547883
MDR Text Key207370194
Report Number9612501-2020-01327
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 01/06/2021
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 Date11/30/2022
Device Model Number176630
Device Catalogue Number176630
Device Lot NumberJ9M1827Y
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2020
Initial Date Manufacturer Received 09/01/2020
Initial Date FDA Received09/17/2020
Supplement Dates Manufacturer Received11/13/2020
12/23/2020
Supplement Dates FDA Received11/24/2020
01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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