MAUDE Adverse Event Report: ETHICON INC. BLAKE DRAIN UNKNOWN PRODUCT; CATHETER, IRRIGATION

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

Patient Problems Failure to Anastomose (1028); Wound Dehiscence (1154); Bacterial Infection (1735); Fistula (1862); Sepsis (2067)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information has been requested however not received to date.If further details are received at a later date a supplemental medwatch will be sent.Does the author/surgeon believe that ethicon product: blake drain involved caused and/or contributed to deaths? anastomotic leakage, wound dehiscence, empyema, vascular fistula, sepsis, intraabdominal abscess does the author/surgeon believe there was any deficiency with the ethicon: blake drain, used for all cases in this study? if yes, please provide patient demographics for each of the 5 death cases with post-op complications (anastomatic leak)? were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Would the author/surgeon like to speak with ethicon medical safety and engineering via scheduled conference call regarding the products involved in the death cases? has an autopsy been performed for death cases? if so, can the results be shared? 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.Citation: ann surg oncol (2021) 28:8996¿9007 https://doi.Org/10.1245/s10434-021-10365-8, journal article.Note: events reported on mw# 2210968-2022-00059, mw# 2210968-2022-00060, mw# 2210968-2022-00061, mw# 2210968-2022-00062, and mw# 2210968-2022-00063.

Event Description

Title: algorithmic approach using negative pressure wound therapy improved survival for patients with synchronous hypopharyngeal and esophageal cancer undergoing pharyngolaryngoesophagectomy with gastric tube reconstruction.This study retrospectively analyzed the feasibility and surgical outcome of an algorithmic approach using negative pressure wound therapy for patients with synchronous hypopharyngeal and esophageal cancer undergoing pharyngolaryngoesophagectomy with gastric tube reconstruction.Patients undergoing ple and gastric tube reconstruction for hypopharyngeal cancer between 2011 and 2019 were included in our study.The study enrolled 43 patients.A conventional surgical drain j-vac drain ethicon or npwt is placed in the neck area as per the surgeon¿s preference.The conventional surgical drain is removed according to the drainage color and amount.All the patients in this study were followed up until the end of 2019.Reported complications reported anastomotic leakage (n=13), anastomotic leakage related complications : wound dehiscence (n=4), empyema (n=2), vascular fistula (n=3) and sepsis (n=1) ,intraabdominal abscess.(b)(6) male died due to empyema with septic shock.(b)(6) male died due to anastomotic leakage related complication.(b)(6) male died due to anastomotic leakage related complication.(b)(6) male died due to anastomotic leakage anastomotic leakage related complication.(b)(6) male patient died during the index hospitalization, within 90 days postoperatively, because of a deadly leakage- associated complication.In conclusion negative pressure wound therapy with an algorithmic approach improved the overall survival for the patients undergoing gastric tube reconstruction after pharyngolaryngoesophagectomy for hypopharyngeal and esophageal cancer by preventing deadly complications secondary to anastomotic leakage.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA SILICON LTD.-INDIA; 251, sector-6, imt manesar; gurgaon 12205 0; IN 122050
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13161432
• MDR Text Key: 288317827
• Report Number: 2210968-2022-00064
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: CL I 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2021
• 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