MAUDE Adverse Event Report: ETHICON INC. LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT; CLIP, IMPLANTABLE

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

Patient Problems Fistula (1862); Unspecified Tissue Injury (4559)

Event Date 03/10/2022

Event Type  Injury  

Event Description

Title: laparoscopic bailout surgery effective procedure for patients with difficult laparoscopic cholecystectomy.This retrospective study aims to examine bailout surgery (bos) cases and clarify the effectiveness of bailout surgery (bos).Between january 2006 december 2020, data from 57 patients who were underwent bailout surgery (bos) at the department of gastroenterological surgery, ibaraki medical center, tokyo medical university were retrieved and analyzed.The patients were divided into two groups: open bailout surgery (bos) group (open-b g) with 38 patients (22 males and 16 females) age 71.7 (30.1¿88.5 years ) and laparoscopic bailout surgery (bos) group (lap-b g) with 19 patients (14 males and 5 females) age 72.1 (32.1¿91.2 years).Furthermore, the cystic duct closing techniques were divided into two groups, suture method (reconstituting or fenestrating; suture g: s-g) and the clipping or ligation method (clipping or ligation g: cl-g).In cases where cystic duct has been identified, a ligature using endloops ® (ethicon, johnson and johnson, arlington, tx, usa) was selected , or clipping closure.For cases where the cystic duct cannot be encircled, and bile juice leakage has been confirmed, suturing (reconstituting or fenestrating) closure of cystic duct was selected.In recent laparoscopic bailout surgery (bos) cases, we have selected continuous suture reconstituting and omentum covering using lapra ty ® suture clips (ethicon, johnson and johnson, arlington, tx, usa) in cases of fragile and thickened gallbladder wall.Suture closing group (s-g) had 22 cases (16 males and 6 females) age 70.8 (30.9¿88.3years ) (5 cases underwent laparoscopy) and clipping or ligature closing group (cl-g) had 35 cases (20 males and 15 females) age 70.4 (30.1¿88.5 years ) (14 cases underwent laparoscopy).In suture closing group (s-g), three of five cases were operated using lapra ty ® suture clips under laparoscopy.Reported complications included: in suture closing group (s-g): (n=1) suffered from postoperative biliary fistula under laparoscopy with suture closing for cystic duct.(n=2) fenestrating suture closure of cystic duct under laparotomy.(n=1) vascular biliary injuries.In clipping or ligature closing group (cl-g): (n=1) vascular biliary injuries.(n=1) postoperative bile leakage.It was concluded , that both bailout surgery (bos) procedures were effective procedures to avoid bdi.The decision to whether to conduct bos via laparotomy, or to conduct bailout surgery (bos) within laparoscopic cholecystectomy (lc), is yet unclear.It still has to rely on decision of scrub-in attending surgeons.However, if the patients had uncontrolled bleeding, it should be conversion to laparotomy and doing bailout surgery (bos).Bailout surgery (bos) with preoperative el cases were increasing risk of performing cystic duct reconstructing suture closure.

Manufacturer Narrative

Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.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 surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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 number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: updates in surgery https://doi.Org/10.1007/s13304-022-01266-w.

Manufacturer Narrative

(b)(4).Date sent to the fda: 8/8/2022.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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: LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15146651
• MDR Text Key: 297052091
• Report Number: 2210968-2022-06177
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention