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

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Hematuria (2558); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 through a journal article.No specific patient information regarding events has been provided and it is unknown if the events have been previously reported.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.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 there was any deficiency with the ethicon products used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved caused and/or contributed to the adverse events described in the article?.

Event Description

It was reported in a journal article entitled: the safety and efficacy of adjuvant hemostatic agents during laparoscopic nephron-sparing surgery: comparison of tachosil and floseal versus no hemostatic agents authors: senol tonyali, artan koni, sertac yazici, and cenk y.Bilen citation: laparoscopic nephron-sparing surgery-tonyali et al.Laparoscopic urology vol.15 no.01, january-february 2017.The aim of this retrospective study was to evaluate the impact of using tachosil and floseal on surgical outcomes of laparoscopic nephron-sparing surgery (lnss) such as operation time, intraoperative ischemia time, hospital stay and postoperative complications, especially hemorrhage and urinary leakage.Between july 2007 and june 2015, a total of 79 patients who underwent lnss were included.The patients were divided into 3 categories: no adjuvant hemostatic agent (aha) group: n = 18 (12 males and 6 females; age range: 55.7 ± 8.6; mean bmi: 24.8 ± 3.2); tachosil group: n = 25(17 males and 8 females; age range: 57.2 ± 9.6; mean bmi: 29.5 ± 5); floseal group: n = 36 (28 males and 8 females; age range: 51.2 ± 11.7; mean bmi: 25.3 ± 3.3).During the procedure, following tumor resection using cold scissors, the tumor bed was sutured using 2.0 vicryl for hemostasis of vessels and closure of the collecting system.Thereafter, parenchymal hemostasis was achieved by approximating both edges using continuous 1.0 vicryl sutures around a surgicel bolster placed in the tumor bed.Tachosil or floseal was layered before placement of a surgicel bolster.In all, 3 patients in the floseal group had hematuria on first or second postoperative day, which lowered the hemoglobin level and was treated conservatively with blood transfusion.Additionally, 1 patient in the tachosil group required blood transfusion due to a rectus hematoma on the trocar tract.In conclusion, both tachosil and floseal can be considered safe and effective, and easy to use adjuvant treatments during lnss.They might be useful especially in preventing pseudo aneurisms, decreasing postoperative drainage and shortening intraoperative ischemia time and hospital stay.Additional information has been requested.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• Type of Device: HEMOSTATIC AGENT, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7577827
• MDR Text Key: 110357108
• Report Number: 2210968-2018-73352
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: N12159
• 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: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2018
• 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