MAUDE Adverse Event Report: ETHICON INC. SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number 1961

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Pulmonary Edema (2020); Fluid Discharge (2686)

Event Date 12/02/2021

Event Type  Death  

Event Description

It was reported that a patient underwent a cholecystectomy procedure on (b)(6) 2021 and absorbable hemostat was used.An (b)(6) year old female patient with cholecystitis underwent cholecystectomy.The surgery was prolonged due to cholecystitis, severe adhesions and bleeding from the liver bed that couldn't be stopped with diathermia or tamponade.Hemostat treatment was used to stop the bleeding adjacent to the liver bed.The surgeon believes he used one or two units of 2.5x5cm.The lot number is unknown.According to the surgeon the use of the hemostat is not recorded in the surgery report as this is not the type of product he would normally record.On (b)(6), the patient was diagnosed with infection and re-hospitalized.The patient was treated with antibiotics and underwent a ct guided drainage procedure to drain the collection.On (b)(6), the patient was admitted to a second surgery carried out by a different surgeon during which the hemostat was removed and a leakage in the gallbladder was observed and was closed with a suture.No gallbladder collection was observed.The patient had cultures take both on (b)(6) came back with klebsiella pneumoniae.On (b)(6) the patient passed away.The reported cause of death was ards, - lungs edema not from the heart.According to the surgeon, the infection could have been caused by various contributors including: bile, reusable surgical instruments, etc.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a 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.

Manufacturer Narrative

Product complaint#: (b)(4).Additional information was requested, and the following was obtained: 1.Please provide the following patient demographic information, if available: weight and bmi at the time of index procedure? 28.7 bmi.2.What were the diagnosis and indication for the index surgical procedure? state post cholecystosis.3.Please provide any relevant patient history: 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.Diapedeses, hypertension, c-section.4.It¿s stated that the surgeon believes the absorbable hemostat may have been surgicel.Please confirm that surgicel product code 1961 was used.It's most likely to be 1961.5.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? active bleeding.6.Where was the surgicel used (on what tissue)? above the tissue.7.How much surgicel was used during the procedure? 2 pieces 2.5/5.8.How was the surgicel placed? above the tissue.9.What is physician¿s opinion as to the etiology of or contributing factors to this event? bleeding+ infflamanted area + surgical (foreign body).10.What was the antibiotic therapy used to treat the patient¿s infection? invanz.The following information was requested, but unavailable: 1.Was there an alleged deficiency of the surgicel that may have cause or contributed to the patient¿s post-operative infection? 2.Was there an alleged deficiency of the surgicel that may have cause or contributed to the patient¿s post-operative death?.Event related to mw#: 2210968-2022-01893.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM)
• 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: 13307511
• MDR Text Key: 284125389
• Report Number: 2210968-2022-00537
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031003118
• UDI-Public: 10705031003118
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

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 Model Number: 1961
• Device Catalogue Number: 1961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/18/2022
• 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
• Patient Age: 82 YR
• Patient Sex: Female