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 Problems Failure to Anastomose (1028); Abscess (1690); Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4)- device not returned.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: [the patient¿s demographics] the patient initials are (b)(6).(b)(6) years old male.His height is 173 cm.Weight is (b)(6) kg.[current status of the patient] the patient has been hospitalized.[progress] administration of antibiotics is ongoing in the ward.Abscesses were almost removed via catheter (2 l) by the surgeon.[adverse event contents] urinary peritonitis due to anastomotic failure [treatment contents] initially 10 days (the patient was discharged on postoperative day 7.) grade 3a (dingo classification).A drain was re-placed.The patient visited the hospital immediately after postoperative day 8 due to poor condition and was immediately admitted to the hospital.[treatment plan] reoperation is planned if the anastomosis does not heal spontaneously when inflammation subsides.[seriousness] serious.[the reason of the seriousness] peritonitis developed.[product use details] on april 20, the robot-assisted radical prostatectomy was performed.Use of energy devices was minimal for nerve-sparing case.Hemostasis was performed by applying surgicel powder to oozing after prostatectomy.After hemostasis was completed, unnecessary excess powder was washed and removed with saline.Urethrovesical anastomosis was then performed.[surgeon¿s opinion about causal relationship between product and event] there was causal relationship between the product and event.[surgeon¿s comments] timing of use.It may have been a problem to use it at the same timing as a surgicel sheet.(the clot remained at the anastomotic site, resulting in the crusting overlapping each other and impaired wound healing.).In the past, 150 leak tests were performed without any problems, postoperative drain was removed in 3 days, and delayed anastomotic insufficiency did not occur in 1500 cases.It was thought that the patient became urinary retention, and it became anastomotic insufficiency.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.What 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.What is the lot number? how much surgicel was used during the procedure? what were current symptoms following the index surgical procedure? onset date? were cultures performed? if yes, results? has any surgical or medical intervention been performed? was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative course? what is the patient¿s current status? can you provide more information on the surgicel sheet? can you please provide more detail regarding the abscess removed by the catheter? what is the anatomical location of the abscesses and procedure to remove them? why does the surgeon believe that the surgicel powder caused or contributed to the anastomotic leak? is there an alleged deficiency with the surgicel sheet that caused or contributed to the event? if so, what are the product code and lot number? 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 robot-assisted radical prostatectomy procedure on (b)(6) 2021 and absorbable hemostat was used.The product was used for oozing from the posterior wall of the prostate and anterior wall of the rectum before urethrovesical anastomosis.After hemostasis was confirmed, it was washed with physiological saline, the posterior wall was reinforced with suture, and urethrovesical anastomosis was performed.On (b)(6) 2021, it was reported that the patient developed peritonitis due to anastomotic failure.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 5/25/2021.Additional information was requested, and the following was obtained: what were the diagnosis and indication for the index surgical procedure? radical prostatectomy.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.What is the lot number? no further information is available.How much surgicel was used during the procedure? no further information is available.What were current symptoms following the index surgical procedure? onset date? the patent condition is getting improve but the patient is still in hospital.(confirmed at (b)(6)).Were cultures performed? if yes, results? no further information is available.Has any surgical or medical intervention been performed? administration of antibiotics is ongoing in the ward.Abscesses were almost removed via catheter (2 l) by the surgeon.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative course? it was commented that, it may have been a problem to use it at the same timing as a surgicel sheet.(the physician used surgicel sheet at past procedures and this comment point the past procedures).What is the patient¿s current status? the patient has been hospitalized.Can you provide more information on the surgicel sheet? surgicel sheet was not used for this procedure.Can you please provide more detail regarding the abscess removed by the catheter? what is the anatomical location of the abscesses and procedure to remove them? no further information is available.Why does the surgeon believe that the surgicel powder caused or contributed to the anastomotic leak? it was commented that, it may have been a problem to use it at the same timing as a surgicel sheet.The clot remained at the anastomotic site, resulting in the crusting overlapping each other and impaired wound healing.Is there an alleged deficiency with the surgicel sheet that caused or contributed to the event? if so, what are the product code and lot number? no further information is available.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.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11855855
• MDR Text Key: 251708003
• Report Number: 2210968-2021-04801
• 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: 05/10/2021

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
• Device Model Number: 3013SP
• Device Catalogue Number: 3013SP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 05/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 88