MAUDE Adverse Event Report: ETHICON INC. J-VAC BULB RESERVOIR UNKNOWN PRODUCT; CATHETER AND TIP SUCTION

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

Patient Problem Failure to Anastomose (1028)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).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 note, j-vac is a reservoir used in conjunction with a drain.Please clarify if an ethicon drain was used and the name of the ethicon drain product (blake drain) was used in the patient.Does the surgeon believe that ethicon products (blake drain and j-vac reservoir) involved caused and/or contributed to the post, operative complications (anastomotic leakage) described in the article? does the surgeon believe there was any deficiency with the ethicon products (blake drain and j-vac reservoir) used in this procedure? if yes, please provide patient demographics for the patients that experienced the post-operative complications (anastomotic leakage).Were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Were the cases discussed in this article previously reported to ethicon? if yes, please provide complaint reference numbers.Does the surgeon believe that ethicon product, j-vac drainage system involved, caused and/or contributed to the adverse events of anastomotic leakage described in the article: "analysis of risk factors for anastomotic leakage after lower rectal cancer resection, including drain type: a retrospective single center study"? if yes, please provide event details including: initial procedure date.Procedure name.Specific patient demographics.Where was the procedure performed? event date.Specific medical/surgical intervention.Ethicon product involved; product code and lot number.Patient pre-existing conditions/other relevant patient history/concomitant medications.Are any devices available for evaluation? 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Note: events reported on mw# 2210968-2021-00891.Citation: doi: https://doi.Org/10.1186/s12876-020-01462-1.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 a journal article that a reservoir was used.Title: analysis of risk factors for anastomotic leakage after lower rectal cancer resection, including drain type: a retrospective single center study.Authors: tetsushi kinugasa, sachiko nagasu, kenta murotani, tomoaki mizobe, takafumi ochi, taro isobe, fumihiko fujita, yoshito akagi.Citation: doi: https://doi.Org/10.1186/s12876-020-01462-1.The authors investigated the correlations between surgery-related factors and the incidence of anastomotic leakage after low anterior resection (lar) for lower rectal cancer.A total of 630 patients underwent colorectal surgery between 2011 and 2014 in the department.Of these, 97 patients (76 male and 21 female patients; age range: 34 to 83 years old) underwent lar and were enrolled in the retrospective study.Temporary ileostomy was performed in all patients, and no patients received preoperative chemoradiation.Surgeons in the department chose closed drainage or open drainage depending on the characteristics of the operation.The authors inserted a drain in all cases of lar.However, it is up to the surgeon to decide which drain to use.The drain was classified as one of two types: open (group o; 56 patients) or closed (group c; 41 patients).In group c patients, j-vac drainage system (ethicon) was used.Reported complications included anastomotic leakage (n-21).Anastomotic leakage is a major postoperative complication after lower rectal surgery and is associated with high postoperative morbidity and mortality, functional defects, and poor oncological outcomes.Anastomotic leakage is a multifactorial complication after lar.Patients¿ characteristics cannot be changed, but novel devices and technical improvements could prevent this complication.In this study, the authors demonstrated that in patients with anastomotic leakage after lar, leakage frequency was higher in those with underlying disease, who underwent transanal hand-sewn anastomosis, and in those with closed drainage.The study findings suggest that it is essential to determine the need for a drain and to select the drainage method after a comprehensive assessment of the surgical procedure and the patient¿s condition.

• Brand Name: J-VAC BULB RESERVOIR UNKNOWN PRODUCT
• Type of Device: CATHETER AND TIP SUCTION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): DEGANIA SILICON LTD.-ISREAL; degania bet; emek hayarden 15130 ; IS 15130
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11262992
• MDR Text Key: 234287454
• Report Number: 2210968-2021-00892
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CL II EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2021

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
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 02/01/2021
• 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