MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP APPLIER UNKNOWN PRODUCT; APPLIER, SURGICAL, CLIP

Catalog Number LIGAPPUNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.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: please verify the specific types of complications the patients experienced with the use of the ethicon devices.Does the author/surgeon believe that the ethicon devices (harmonic, echelon, ligaclip applier) caused or contributed to the patient complications mentioned in the article? if yes, please explain.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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via journal article; title: laparoscopic anterior hepatic transection for resecting lesions originating in the paracaval portion of the caudate lobe (with videos).Authors: tian-ge sun, xiao-jun wang, li cao, jian-wei li, jian chen, xue-song li, ke-xi liao, yong cao, shu-guo zheng.Citation: surgical endoscopy (2021) 35:5352¿5358, https://doi.Org/10.1007/s00464-021-08455-5.This study aimed to evaluate the safety and feasibility of laparoscopic anterior hepatic transection for resecting paracaval-originating lesions.Between august 2017 and april 2020, 15 patients who underwent laparoscopic anterior hepatic transection for paracaval-originating lesion resection were included in the study.The patients included 8 males and 7 females with a median age of 51 years (range, 21¿62 years).During the anterior hepatic parenchyma transection, an ultrasonic scalpel (ethicon endo-surgery) was used to transect the liver parenchyma cranially along the hepatic midplane, exposing the left or right wall of the middle hepatic vein, showing that the lesion adhered closely to the middle hepatic vein.The small branches of the hepatic veins and pedicles encountered were clipped and divided with vascular clips using a continuous titanium clips (ethicon-endosurgery) or 4 other competitors vascular clips.If the thick veins of segments v and viii were encountered, they could be divided with an endoscopic linear cutter using (echelon flex 60, ethicon endo-surgery, usa).During the lesion resection, once the lesion was removed, the raw surface was treated with an unknown manufacturer bipolar coagulation to achieve hemostasis and repeatedly washed until no bleeding or bile leakage was confirmed.Actively bleeding vessels were sutured with 5¿0 prolene (ethicon).The reported complications included the following: patient 1, a 33-year-old female had an unspecified complication (clavien dindo grade i) without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.Patient 2, a 54-year-old female had an unspecified complication (clavien dindo grade i) without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.Patient 3, a 25-year-old male had an unspecified complication (clavien dindo grade iii) requiring surgical, endoscopic or radiological intervention.Patient also had an introperative blood loss of 3600 ml.Patient 4, a 21-year-old male had an unspecified complication (clavien dindo grade i) without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.Patient 5, a 51-year-old female had an unspecified complication (clavien dindo grade i) without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.Patient 6, a 62-year-old male had an unspecified complication (clavien dindo grade iii) requiring surgical, endoscopic or radiological intervention.Patient 7, a 46-year-old female had an unspecified complication (clavien dindo grade iii) requiring surgical, endoscopic or radiological intervention.Patient 9, a 21-year-old male had an unspecified complication (clavien dindo grade iii) requiring surgical, endoscopic or radiological intervention.Patient 10, a 53-year-old male had an unspecified complication (clavien dindo grade iii) requiring surgical, endoscopic or radiological intervention.Patient 11, a 56-year-old male had an unspecified life-threatening complication (clavien dindo grade iv) requiring intermediate care or intensive care unit management.Patient 12, a 62-year-old female had an unspecified complication (clavien dindo grade i) without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.Patient 13, a 42-year-old female had an unspecified complication (clavien dindo grade i) without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.Patient 14, a 51-year-old female had an unspecified complication (clavien dindo grade i) without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.In conclusion, although technically challenging, laparoscopic anterior hepatic transection is still a safe and feasible procedure for resecting paracaval-originating lesions in select patients.

• Brand Name: LIGACLIP APPLIER UNKNOWN PRODUCT
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15673643
• MDR Text Key: 302434220
• Report Number: 3005075853-2022-07243
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LIGAPPUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention