MAUDE Adverse Event Report: ETHICON INC. SURGICEL ABSORBABLE HEMOSTAT UNKNOWN; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

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

Patient Problems Septic Shock (2068); Peritonitis (2252)

Event Date 06/22/2021

Event Type  Death  

Manufacturer Narrative

Product complaint #: (b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number(s).Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative patient consequences described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? can you identify the product code and lot number of the product that was used in each procedure? can specific patient demographics initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates of study drugs be provided? would the author/surgeon like to speak with ethicon medical safety and engineering via scheduled conference call regarding the product involved in these events? citation:clinical and experimental gastroenterology 2021:14 297¿302.Event related to mw # 2210968-2021-08285.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: title: hepatectomy with takasaki¿s technique using sonastar ultrasonic aspiration system: an experience from 58 cases.Authors: van linh ho, nhu hien pham, thanh xuan nguyen, an phong tran, nhu thanh dang, nhu hiep pham.Citation:clinical and experimental gastroenterology 2021:14 297¿302.A retrospective study was conducted on 58 patients who underwent hepatectomy with takasaki¿s technique using sonastar in hue central hospital from 01/2018 to 02/ 2021.The mean age was 60.7 ± 10.5 (25¿80) years.There were 57 (98.3%) patients with a medical history of hepatitis b or c (51 hepatitis b).Most patients were classified as child-pugh stage a and performance status (ps) 0.All patients had platelet counts over 100.000/mm3 and normal coagulation panel.The mean of serum afp level was 379 ± 110.7 (11.5¿1660) ng/ml.Final inspection was performed to identify sites of bile leak or hemorrhage from the transection surface, which were then reinforced by suture.Surgicel(ethicon) was then placed on the transection surface.An abdominal drain was placed under the liver and exteriorized on the right flank.Reported complications included biliary leakage which lead to bile peritonitis requiring second operation in the fifth day postoperatively.The patient was dead in the two days after the second operation cause of nonrecoverable septic shock (n=1) , hepatic failure (n=1), ascites (n=2), abscess (n=1).In conclusion hepatectomy using takasaki technique with sonastar ultrasonic aspiration system is safe, effective, allowing an anatomical resection with sufficient safety margin and resulting in low complication rates (liver failure, biliary leakage) and good survival outcomes.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• 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
• MDR Report Key: 12454019
• MDR Text Key: 270853113
• Report Number: 2210968-2021-08286
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2021

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: 08/20/2021
• Initial Date FDA Received: 09/10/2021
• 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): Death; Required Intervention