MAUDE Adverse Event Report: ETHICON INC. SURGICEL POWDER USA - ABSORBABLE HEMOSTATIC PWDR; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number 3013SP

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

Patient Problem Pleural Effusion (2010)

Event Date 11/16/2020

Event Type  Injury  

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.Additional information was requested, and the following was obtained: accumulation of pleural effusion occurred after the surgery, then, drainage was performed.After being discharged from the hospital temporarily, the patient was hospitalized again on november 17 due to accumulation of pleural effusion.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.Please provide the following patient demographic information, if available: age, weight, bmi at the time of index procedure? what are were the diagnosis and indication for the index surgical procedure? 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.Was there any intraoperative concurrent use of other products? where was the surgicel used (on what tissue)? how much surgicel was used during the procedure? was the surgicel product left in place? has any surgical or medical intervention been performed? what is physician¿s opinion as to the etiology of or contributing factors to this event? was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative pleural effusion? what is the patient¿s current status? was the surgicel used to address active bleeding or used prophylactically? a manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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 that a patient underwent a left lobectomy procedure on (b)(6) 2020 and absorbable hemostat was used.The absorbable hemostat was applied on the 7th dissection part, and hemostasis was performed.The affected area was cleaned with running water, and the excessive absorbable hemostat was aspirated.On (b)(6) 2020, it seemed that there was still pleural effusion corrected in the patient¿s body.The male patient remains hospitalized.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 1/21/2021.H6 component code: g07002 - device not returned.Additional information was requested, and the following was obtained: 1.Please provide the following patient demographic information, if available: age, weight, bmi at the time of index procedure? the patient is male.2.What are were the diagnosis and indication for the index surgical procedure? lower left lung lobectomy.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.No further information is available.4.Was there any intraoperative concurrent use of other products? no further information is available.5.Where was the surgicel used (on what tissue)? the surgicel powder was applied on the 7th dissection part.6.How much surgicel was used during the procedure? no further information is available.7.Was the surgicel product left in place? the affected area was cleaned with running water, and the excessive powder was aspirated.8.Has any surgical or medical intervention been performed? the pleural effusion was drained.9.What is physician¿s opinion as to the etiology of or contributing factors to this event? surgicel powder was used in two cases, but no issues happened in the first case.This issue occurred in the second case, so it was supposed to be adventitious.The surgeon stopped using surgicel powder for lobectomies, but will try using it in surgeries for mediastinal tumor and pleural biopsy.10.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative pleural effusion? no further information is available.11.What is the patient¿s current status? the patient has been re-hospitalized since (b)(6) 2020.12.Was the surgicel used to address active bleeding or used prophylactically? hemostasis for active bleeding.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 POWDER USA - ABSORBABLE HEMOSTATIC PWDR
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10989124
• MDR Text Key: 220894491
• Report Number: 2210968-2020-09847
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031237506
• UDI-Public: 10705031237506
• Combination Product (y/n): N
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

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 Expiration Date: 10/31/2021
• Device Model Number: 3013SP
• Device Catalogue Number: 3013SP
• Device Lot Number: QEBCZL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 01/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention