MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Catalog Number LTXXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hematoma (1884)

Event Date 07/25/2022

Event Type  Injury  

Event Description

It was reported via journal article: title: a novel technique of sutureless omentopexy during dual-incision laparoscopic peritoneal dialysis catheter insertion to prevent catheter dysfunction due to omental wrapping author(s): hao-wei kou, chun-nan yeh, chun-yi tsai, chao-wei lee, jun-te hsu, shang-yu wang, ming-chin yu, wen-hsin chen, chien-chih chiu, tsann-long hwang citation: surgical endoscopy (2023) 37:148¿155, https://doi.Org/10.1007/s00464-022-09449-7 the present study aimed to introduce a sutureless method of performing omentopexy during dual-incision laparoscopic peritoneal dialysis catheter insertion.Between january 2013 and may 2020, 469 patients (236 males and 233 females) who underwent laparoscopic peritoneal dialysis catheter insertion were included in the study.The mean age of our patient population was 50.3 ± 16.5 years (range, 10¿95 years).The patients were categorized into the omentopexy (n = 81) and non-omentopexy (n = 388) groups.For the patients who underwent omentopexy, the inferior edge of the omentum was identified and fixed to the round ligament of the liver using titanium clips (ligaclip® extra ligating clip, large; ethicon endo-surgery).The fixation was usually repeated 3 to 4 times in different directions to keep the omentum away from the pelvic cavity.Reported complications included persistent bloody dialysate and intra-abdominal hematoma after surgery (n=1).In conclusion, sutureless omentopexy during laparoscopic peritoneal dialysis catheter insertion is a safe and reliable technique that does not require additional incisions and suturing.Routinely performing omentopexy provides clinical benefits by reducing the risk of catheter dysfunction due to omental wrapping.

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.

• Brand Name: LIGACLIP EXTRA TITANIUM CLIPS
• 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: 17845017
• MDR Text Key: 324609223
• Report Number: 3005075853-2023-07029
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LTXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention