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

Model Number ER420

Device Problems Failure to Form Staple (2579); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure to Anastomose (1028)

Event Date 12/11/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Additional information was requested and the following was obtained: "the lot number of ip-01608225 might be x95e5t, x95f2a, x95k5f, x95r8z or x95f29.How was the leak discovered? no further information will be available.Were the clips visualized endoscopically during the initial surgical procedure? no further information will be available.It was stated that ""cystic duct was cut after the device clipped"", was the clip fully advanced and visualized in the jaws prior to firing? no further information will be available.Did the device deliver a scissored clip which cut the structure? no further information will be available.Did the device deliver a properly formed clip which cut the structure? there was no issue during the procedure.Did the clip not feed into the jaws, resulting in the jaws cutting the structure upon firing? no further information will be available.At what firing did this occur? no further information will be available.Stated that "it was found that the clip has fallen off by the photo".Could you please provide the photo? no.Has there been a reoperation? if so laparoscopic or open? if the leakage won't stop, they will perform the operation.No further information will be available." an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

Event Description

It was reported that few days after a cholecystectomy, bile leak occurred.It was found that the clip has fallen off by the photo.At the initial operation, cystic duct was cut after the device clipped the cystic duct, and there was no problem during the operation.Catheter balloon was placed on 11th dec and followed up.The surgeon is planning the re-operation if the leakage won¿t stop.The hospitalization has been prolonged, and the patient is still hospitalized.The surgeon¿s comment: i have been using the for long time and there was no problem.If the report is not returned, re-operation will be performed with the er320 or el5ml instead of er420.Another device was used to complete the case.

Manufacturer Narrative

(b)(4).Date sent: 1/19/2023.Additional information was requested and the following was obtained: "it was stated that if the leakage did not stop, a reoperation would be performed.Has there been a reoperation? => no further information will be available.If yes: -was the reoperation laparoscopic or open? => no further information will be available.-what was observed at the site of the leak upon reoperation? => no further information will be available.-how was the leak addressed? => catheter balloon was placed on 11th dec and followed up.The clip formed properly when it was checked from the picture after the operation.The patient is recovering without reoperation.".

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16068881
• MDR Text Key: 306344881
• Report Number: 3005075853-2022-08999
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization