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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. APPLICATIONSGRASPER MIDDLE FOR LIGACLIP; OPEN SURGERY LIGATION CLIP APPLIER

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ETHICON ENDO-SURGERY, LLC. APPLICATIONSGRASPER MIDDLE FOR LIGACLIP; OPEN SURGERY LIGATION CLIP APPLIER Back to Search Results
Catalog Number LC3010Z
Device Problem Difficult to Open or Close (2921)
Patient Problem No Code Available (3191)
Event Date 04/29/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Following information requested but unavailable: was the clip applier inspected for proper jaw align prior to the procedure? what is the history of lubrication of the device? was the lc800 clip base used for clip cartridge to load clips in jaws? how many pds clips were placed proximal and distal? what was the code of the clips? what was the alleged deficiency of the clip? why does the surgeon believe the cystic duct leak is related to clip applier? what is the serial number of the device? how long has it been in use? investigation summary: the analysis results confirmed that the lc3010z device was returned with the jaws closed and with a clip stuck on the jaws.Further analysis dry body fluids were present, preventing the device jaws from opening.The device was forced open and it was able to open the jaws and release the clip, no tissue was noted between the jaws.Once the jaws were open the device was tested and it loaded, retained and formed the clips as intended.In addition, please be informed that both lot numbers (08/18 and 14/11) of the components for the lc3010z was never delivered in this combination in 2018.The event described could not be confirmed as the device performed without any difficulties noted.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.  the certificate records are accessible through external manufacturing. .
 
Event Description
It was reported that the surgeon was not able to open the instrument, so there is also tissue between the branches.Pds clips were put beneath and above and the device was cut out.Post-op patient suffered from leakage of gall bladder at ductus cysticus.Stents were implanted via ercp.
 
Manufacturer Narrative
(b)(4).H10: corrected data (h1) - upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event, and is being considered not reportable.This product and similar products are not sold in the us and therefore is exempt from medical device reporting.
 
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Brand Name
APPLICATIONSGRASPER MIDDLE FOR LIGACLIP
Type of Device
OPEN SURGERY LIGATION CLIP APPLIER
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key8950945
MDR Text Key160887181
Report Number3005075853-2019-21615
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberLC3010Z
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2019
Initial Date Manufacturer Received 07/31/2019
Initial Date FDA Received08/30/2019
Supplement Dates Manufacturer Received01/14/2020
Supplement Dates FDA Received01/15/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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