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 Failure to Anastomose (1028); Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/19/2017

Event Type  Injury  

Event Description

It was reported via journal article; title: the preliminary experience of two-step hepatectomy in treatment of hepatic alveolar echinococcosis invaded the second and the third porta hepatis author(s) : fang dan, chen zheyu, yang kangming, chen kefei, huang xiang, ma zhi, li zhihong, tang youyin, xie jie, wei gengfu citation: chinese journal of bases and clinics in general surgery, sept.2017, vol.24, no.9, doi: 10.7507/1007-9424.201708020 the objective of the study was to discuss the clinical application of two-step hepatectomy for hepatic alveolar echinococcosis which invaded the second and third porta hepatis.Between january 2013 and june 2017, 60 patients with hepatic echinococcosis who underwent step-by step resection were included in the study.There were 28 males and 32 females with a mean age of 35.62 years (range, 15 to 54 years).During the procedure, the liver was incised using the harmonic scalpel system and clamping (ethicon endo-surgery).The tube with the diameter of less than 3 mm is directly closed with harmonic scalpel (ethicon endo-surgery); the retention end of the tube with the diameter of more than 3 mm is ligated with silk thread (manufacturer: unknown), and the resection end is clamped with titanium clip (ethicon endo-surgery) for the tube with the diameter of more than 1 cm, the retention end tube is closed with 5-0 vascular (manufacturer: unknown) suture as far as possible.After the recovery of liver function after surgery, the patient was immediately given drug consolidation therapy, orally administered with albendazole tablets for more than 2 years continuously.Liver and kidney function and blood routine were monitored during medication.The reported complications included blood loss (n=35), mild bile leakage (n=3), pleural effusion (n=3), abdominal effusion (n=3), and effusion in operation area (n=10).In conclusion, the two-step hepatectomy in treatment of hepatic alveolar echinococcosis invaded the second and the third porta hepatis can avoid the large fluctuations of intraoperative blood pressure and other vital signs, can increase the safety of surgery and reduce the difficulty and risk of surgery.

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: "does the author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article?" 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.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.

Manufacturer Narrative

(b)(4).Date sent: 12/07/2022 additional information was requested and the following was obtained: all the complications mentioned in the literature were not related to ethicon products.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.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.

• Brand Name: LIGACLIP APPLIER UNKNOWN PRODUCT
• Type of Device: APPLIER, SURGICAL, CLIP
• 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: 15751400
• MDR Text Key: 303234102
• Report Number: 3005075853-2022-07641
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

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: LIGAPPUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention