MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number EL5ML

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Failure to Anastomose (1028); Anemia (1706); Diarrhea (1811); Vomiting (2144); Insufficient Information (4580)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/29/2023.D4: 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?" this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.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: a safety study of laparoscopic single-anastomosis duodeno-ileal bypass with gastric plication (sadi-gp) in the management of morbid obesity.Author/s: istvan bence balint, ferenc csaszar, lajos orban, peter radics, akos farics, gergo manfai, veronika hari, rebeka javor.Citation: langenbeck's archives of surgery (2022) 407:845¿860 https://doi.Org/10.1007/s00423-021-02276-9.This study is aimed to assess the safety and efficacy of sadi-gp based on a prospective cohort of patients recruited consecutively.We believe that combining well researched sadi with gp instead of sg could result in better complication rates and plausible metabolic outcomes.This trial used a cohort of consecutively admitted patients aiming at the assessment of complication rates and efficacy of sadi-gp.Patient recruitment began in (b)(6) 2018 and ended in (b)(6) 2019 (the last operation was performed in (b)(6) 2019).Preoperative evaluation followed by surgery and postoperative follow-up visits (at 1, 3, 6 and 12 months) were planned.Patients between 18 and 65 years, with bmis of > 40 (without comorbidity related to morbid obesity) or > 35 (with comorbidity related to morbid obesity, especially glucose metabolism) were included.Seventeen middle-aged (mean: 40 years) patients were involved in our study; 15 of them were females.Patients who had previous bariatric surgery, who had severe mental disorders (drug addiction, alcohol consumption, the use of antipsychotics), who were regarded as socially vulnerable patients, who were completely immobile, who were unable to understand the purpose of the study and bariatric surgery, who denied or withdrew their informed consent, for whom duodeno-ileal bypass was not performed during surgery or who dropped out before the 6-month follow-up were excluded.The omentum majus was dissected vertically.The ileum was positioned tension-free antecolic and tied to the posterior wall of the duodenal stump by 2/0 polyglactin sutures (surgicryl, smi ag, belgium).The proximal duodenal staple line was excised and a lengthwise ileotomy was made.A running hand-sewn end-to-side duodeno-ileostomy was prepared by a 2/0 polydioxanone barbed suture (v-loc, covidien, ireland) and the line was secured by ligamaxx clips (ethicon inc., usa) if necessary.Reported complications included vomiting (n=3), anastomosis leakage (n=1), diarrhea (n=,9) and hypoproteinaemia (n=14).According to the safety study, sadi-gp is a promising malabsorptive procedure, but a long-term high-volume case series or a randomised controlled trial is necessary to evaluate complication rates and weight-loss outcomes.Emotional dysregulation is common among bariatric surgery patients according to personality inventory data; therefore, psychological follow-up and psychotherapeutic support are necessary for weight-loss maintenance.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• 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: 17844933
• MDR Text Key: 324608116
• Report Number: 3005075853-2023-07026
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K050344
• 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: 09/29/2023

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: EL5ML
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/29/2023
• 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