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

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products (pdsii suture, blake drain, j-vac reservoir) involved caused and/or contributed to the post-operative complications (infection, blood loss >500ml, bile leakage) described in the article? does the surgeon believe there was any deficiency with the ethicon products (pdsii suture, blake drain, j-vac reservoir) used in this procedure? if yes, please provide patient demographics for the patients that experienced the post-operative complications (infection, blood loss >500ml, bile leakage).Were these 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Note: events reported on mw# 2210968-2021-01052, mw# 2210968-2021-01053.Citation: ann gastroenterol surg.2019;3:506¿514.Doi: 10.1002/ags3.12267.

Event Description

Title: giving short-term prophylactic antibiotics in patients undergoing open and laparoscopic hepatic resection.Authors: hiroji shinkawa | shogo tanaka | shigekazu takemura | ryosuke amano | kenjiro kimura | takayoshi nishioka | tokuji ito | toru miyazaki | atsushi ishihara | shoji kubo citation: ann gastroenterol surg.2019;3:506¿514.Doi: 10.1002/ags3.12267.The authors validated the efficacy of giving short-term prophylactic antibiotics in patients undergoing open hepatic resection (ohr) by comparing the incidence of postoperative infectious complications (pic) including surgical site infection (ssi) between patients who received prophylactic antibiotics before and until 24 hours after surgery and those who received the antibiotics before and until 72 hours after surgery.Additionally, the authors evaluated the effect of giving short-term prophylactic antibiotics in patients undergoing laparoscopic hepatic resection (lhr).This retrospective study included 403 patients who underwent hepatic resection for liver tumors with no biliary reconstruction or resection of other organs from april 2012 to december 2017.Of the 403 patients, 218 patients (male 157; age >(b)(6) y: 160; bmi >25kgm/2: 63) underwent ohr, and 185 patients (male131; age >(b)(6)y: 127: bmi >25 kg/m2: 62) underwent pure laparoscopic resection.During ohr, one or two closed abdominal drains (blake silicon drains and j-vac reservoirs; johnson & johnson medical, new brunswick, nj, usa) were generally inserted near the liver transection plane or into the foramen of winslow.Non-placement of abdominal drain was permitted at surgeon's discretion.After closure of the abdominal fascia with interrupted sutures using 0 pds ii threads (johnson & johnson medical), the surgical incision was irrigated with 500 ml saline.The skin was closed using an interrupted subcuticular suture using 4-0 pds ii threads.During lhr, one or two closed abdominal drains (blake silicon drains and j-vac reservoirs; johnson & johnson medical, new brunswick, nj, usa) were generally inserted near the liver transection plane or into the foramen of winslow.Non-placement of abdominal drain was permitted at surgeon's discretion.Reported complications for ohr group included intraoperative blood loss =500 ml (n-108), postoperative complications (=clavien-dindo grade ii) (n-?), bile leakage (n-?), infectious complications (n-36) including surgical site infection (ssi) (n-29) consisting of incisional ssi (n-9) and organ/space ssi (n-24), and remote site infections (n-1) consisting of cholangitis (n-1), reported complications for lhr group included intraoperative blood loss =500 ml (n-9), postoperative complications (=clavien-dindo grade ii) (n-?), bile leakage (n-?), infectious complications (n-3) including surgical site infection (n-3) consisting of organ/space ssi (n-3), the incisional ssi isolated microorganism for both groups included methicillin-resistant staphylococcus aureus (mrsa) (n-2), methicillin-resistant coagulase-negative staphylococci (mrcns) (n-1), coagulase-negative staphylococci; (cns) (n-2), staphylococcus aureus (n-1), enterococcus species (n-1), enterobacter cloacae (n-2) and organ/space ssi isolated microorganism for both groups included enterococcus faecalis (-6), enterobacter cloacae (n-4), mrcns (n-3), staphylococcus aureus (n-4), mrsa (n-2), klebsiella pneumoniae (n-1), candida glabrata (n-1), streptococcus salivarius (n-1), pseudomonas aeruginosa (n-2), bacteroides fragilis (n-1), enterococcus species (n-1), corynebacterium species (n-1).In conclusion, giving short-term prophylactic antibiotics might be sufficient in preventing postoperative infectious complications in patients undergoing open and laparoscopic hepatic resection.

• Brand Name: J-VAC 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): ETHICON INC.-FLEXTRONICS MEDICAL; 1659 gailes blvd; san diego CA 92154
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11276493
• MDR Text Key: 233319756
• Report Number: 2210968-2021-01054
• 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: 01/15/2021

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: 01/15/2021
• Initial Date FDA Received: 02/03/2021
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention