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

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.

• 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 Key: 8950945
• MDR Text Key: 160887181
• Report Number: 3005075853-2019-21615
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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 Number: LC3010Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention