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

Catalog Number SURGICELUNK

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

Patient Problems Abscess (1690); Bacterial Infection (1735)

Event Date 04/01/2020

Event Type  Injury  

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? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.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? citation: the american surgeon april 2020 vol.86.

Event Description

It was reported via a journal article: title: oxidized regenerated cellulose during laparoscopic cholecystectomy increases the risk of rehospitalization.Authors: mohamed abou arisheh, m.D., moris venturero, m.D., paul froom, m.D.Citation: the american surgeon april 2020 vol.86.This retrospective study aimed to present that oxidized regenerated cellulose (orc) is effective in controlling excessive bleeding, improves operative field visibility, and could decrease the risk of conversions from a laparoscopic to an open cholecystectomy but might cause increased morbidity after discharge.Between october 1, 2014 and january 31, 2018, there were 530 laparoscopic operations in which 182 (n=117 female, n=67 with age more than or equal to 65 years) required the use of orc (surgicel) (ethicon) to control bleeding.Prophylactic antibiotics consisted of a single dose of cefazoline were given unless there was evidence of acute cholecystitis when the treatment was ceftriaxone and metronidazole for 5 to 7 days.Complaint included diagnosis of subhepatic abscess (n=7 out of 182 patients treated with orc) where the patients were re-hospitalized.These patients were treated with antibiotics and drainage, and the abscess resolved over 10 to 21 days of hospitalization.The seven patients are as follows: (b)(6) year old male was re-hospitalized after 5 days with symptoms of fever and pain, ct scan showed multiple abscesses with bacteria of enterococcus faecalis, klebsiella pneumonia, and enterococcus faecium and spent 21 days in hospital; (b)(6) year old female was re-hospitalized after 11 days with symptoms of fever and pain, ct scan showed a 7cm abscess with bacteria of klebsiella oxytoca and spent 10 days in hospital; (b)(6) year old male was re-hospitalized after 4 days with symptom of fever, ct scan showed a 5cm abscess with bacteria of k.Pneumoniae, escherichia coli, and e.Faecalis and spent 12 days in hospital; (b)(6) year old female was re-hospitalized after 19 days with symptoms of fever and pain, ct scan showed a 11cm abscess with bacteria of e.Faecium and e.Coli and spent 17 days in hospital; (b)(6) year old female was re-hospitalized after 11 days with symptoms of fever and pain, ct scan showed a 9.5cm abscess with bacteria of e.Coli and k.Pneumoniae and spent 13 days in hospital; (b)(6) year old female was re-hospitalized after 5 days with symptoms of fever and pain, ct scan showed a 6cm abscess with bacteria of enterobacter cloacae and spent 10 days in hospital; (b)(6) year old female was re-hospitalized after 29 days with symptom of pain, ct scan showed multiple abscesses with bacteria of pseudomonas aeruginosa and spent 10 days in hospital.The data presented in the study showed that the use of orc is a rapid way to stop bleeding and improves visibility of the surgical field, cutting down operation time and perhaps conversion rates to open operations, without the potential damage from electrocautery.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10909481
• MDR Text Key: 219363098
• Report Number: 2210968-2020-09369
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2020

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
• Device Catalogue Number: SURGICELUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/26/2020
• 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
• Patient Age: 74 YR