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 Peritonitis (2252)

Event Date 02/10/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a robot assisted laparoscopic prostatectomy procedure on (b)(6) 2023 and absorbable hemostat was used.Peritonitis developed on (b)(6) 2023, so a re-operation was performed.Cleaning was performed appropriately.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Component code: g07002 - device not returned.Attempts have been made to retrieve the device.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.1.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? 2.What were the diagnosis and indication for the index surgical procedure? 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.4.Was there any intraoperative concurrent use of other products? 5.What is the lot number? 6.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? 7.Where was the surgicel used (on what tissue)? 8.How much surgicel was used during the procedure? 9.Was the surgicel product left in place? was the excess irrigated and removed? 10.Were cultures performed? if yes, results? 11.Was any additional surgical or medical intervention been performed after the re-operation? 12.What is physician¿s opinion as to the etiology of or contributing factors to this event? 13.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative peritonitis? 14.What is the patient¿s current status? 15.What is the users experience w/ surgicel powder and other hemostatic agents? 16.Are there samples available to be returned for evaluation? 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.

Manufacturer Narrative

Product complaint # (b)(4).Additional information received: a 2.Patient age at the time of event, a 2.Age unit, a 3.Gender, b 7.Medical history/preexisting condition, d 4.Lot, d 4.Expiration date, h4.Device manufacture date, h 6.Type of investigation.Additional information was requested, and the following was obtained: -patient details : a 74 year-old man with no allergy.Past medical history included cerebral infarction and cardiomyopathy.Underlying disease was prostate cancer.-3g of the product was used for the pelvic floor.After using the powder, washing was completed twice.No hemostatic agent was used other than the powder.-lot number : shbczp.-the patient was discharged from the hospital on (b)(6) 2023 and then subsequently transported by ambulance.However, the date and time of the ambulance transport is unknown.At the time, pus retention was confirmed, and the surgeon diagnosed peritonitis.-it is not known whether the cause of peritonitis was the powder, but it is likely.-after re-operation, the patient's condition has been recovering.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.

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: age, gender, weight, bmi at the time of index procedure? men, 74years old, no allergies, history of cerebral infarction and cardiomyopathy 2.What were the diagnosis and indication for the index surgical procedure? prostate cancer, history of cerebral infarction and cardiomyopathy 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.Prostate cancer 4.Was there any intraoperative concurrent use of other products? the hemostatic agent is powder only and no other products are used.5.What is the lot number? shbczp 6.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? address active bleeding 7.Where was the surgicel used (on what tissue)? pelvic floor 8.How much surgicel was used during the procedure? 3g 9.Was the surgicel product left in place? was the excess irrigated and removed? the surgeon washed twice at surgicel powder area.10.Were cultures performed? if yes, results? no 11.Was any additional surgical or medical intervention been performed after the re-operation? reoperation 12.What is physician¿s opinion as to the etiology of or contributing factors to this event? the surgeon think powder may have caused peritonitis.13.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative peritonitis? yes, the surgeon thinks the peritonitis was related to surgicel powder.14.What is the patient¿s current status? the patient is recovering.15.What is the users experience w/ surgicel powder and other hemostatic agents? we don't know the patient experience, but this was not first time to use surgicel powder.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16389299
• MDR Text Key: 309694824
• Report Number: 2210968-2023-01189
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031237506
• UDI-Public: 10705031237506
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2023

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: 12/31/2023
• Device Model Number: 3013SP
• Device Catalogue Number: 3013SP
• Device Lot Number: SHBCZP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 02/20/2023; 04/13/2023
• Supplement Dates FDA Received: 02/24/2023; 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male