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U.S. Department of Health and Human Services

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

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DAVIS & GECK CARIBE LTD ENDO CLIP; CLIP, IMPLANTABLE Back to Search Results
Model Number 176625
Device Problems Mechanics Altered (2984); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, at the second or third firing to close the cystic duct during a laparoscopic cholecystectomy, a strange sound was heard and the surgeon could not fire the clip.Another device was used, but the same issue occurred.A third device was used and completed the closure of the cystic duct and vessels.There was no patient injury.
 
Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the jaws of the instrument were received out of alignment.The instrument was also partially applied with three remaining clips.Functional evaluation found that the instrument cycled without binding, and the clips ejected from the jaws unformed.It was reported that the clips did not load properly into the jaws as expected, and the device gave unexpected or uncharacteristic audible feedback of normal use.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: instrument is not intended for use as a grasper or dissector.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
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 18750
DO  18750
MDR Report Key10217538
MDR Text Key197143855
Report Number9612501-2020-00942
Device Sequence Number1
Product Code FZP
UDI-Device Identifier10884521057845
UDI-Public10884521057845
Combination Product (y/n)N
PMA/PMN Number
K143644
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number176625
Device Catalogue Number176625
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2020
Date Manufacturer Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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