MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Catalog Number ER420

Device Problem Difficult to Open or Close (2921)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 07/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # t9343c.Device analysis: the analysis results found that the er420 device was returned with a clip in the jaws; the clip was removed in order to inspect the jaws and they were found with no damage.In an attempt to replicate the reported incident, the device was tested for functionality.During the analysis, the device was cycled and it fed, retained and formed the remaining 14 clips as intended.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device batch/lot number (t9343c) (t9367k), and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is meant by ¿the clips would not close?¿ please provide information regarding the actual shape of the clips.What was done intra-op to address the clips that would not close? when the procedure was completed, were all clips confirmed to be on vessel, proper shape and providing proper occlusion? why did the surgeon place the drain? why did the surgeon over-sew the cystic duct versus using another clip applier? what lead the surgeon to schedule the ercp? what was found during the ercp? was there any medical or surgical intervention done during the ercp? what is the current patient status? why are there white stickers across the logo?.

Event Description

It was reported that during a lap cholecystectomy, the clips did not close.A second device was pulled for the case and the clips did not close.A drain was placed, and the case completed by over sewing the cystic duct.The following day on july 15, the patient was scheduled for ercp (endoscopic retrograde cholangio panography).Patient is currently at the facility.

Manufacturer Narrative

(b)(4).Following the initial analysis, the device was received for additional review.The device was received fully assembled with all clips fired out (bonus clip was still remaining in clip track).A visual inspection of the device was performed and no damage or anomalies were observed with the exception of a white sticker that was placed over the handle logo.The jaw aperture was measured and found to be within specification.Knob rotation was checked and found to be functional.Additionally lockout was confirmed to be present.The device was fired through lockout in order to confirm that clip feeding and forming was functional.The bonus clip was able to be fed and formed with no issues noted.The device was then disassembled.The lockout tab was sheared due to firing the device through lockout during this analysis.No other anomalies or defects were noted with the other components/assembly.In conclusion, the device was able to appropriately feed and form the bonus clip and no defects or anomalies were noted.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device batch number (t9343c), and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Additional information requested and received: the hospital cannot share any patient information about this case.The doctor explained that the clips were misaligned and would not close properly.They would not stay secured.The devise was removed from field and a new device was pulled and used.It was the doctors discretion to place a drain for any associate leaks that might happen in the future as a preventative measure.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8852327
• MDR Text Key: 153089283
• Report Number: 3005075853-2019-20940
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: ER420
• Device Lot Number: T9367K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Date Manufacturer Received: 11/19/2019
• Patient Sequence Number: 1