MAUDE Adverse Event Report: ETHICON INC. SURGICEL ORIGINAL 2INX3IN(5.1CMX7.6CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number 1953

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).H6.Component code: g07002 - 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: there was an adverse consequence to the patient.[current status of the patient] - the patient is in the hospital.[progress] - no particular effect on the patient.[health injury details] - nothing in particular.What appeared to be surgicel remained in the body.[treatment details] - none.[treatment plan] - none.[seriousness] - non-serious (moderate/minimal).[reason of the seriousness] - there was no particular health hazard.[product use details] - in (b)(6) 2022, the patient underwent open uterine myoma recurrence surgery.Recurrence : in (b)(6) 2023, the patient underwent re-surgery by laparotomy.Recurrence : in (b)(6) of the same year, the laparotomy was opened to resect the disseminated tumor.The tumor was examined and found to be a stamp.At that time, a 2.5 cm capsule-like object was found near the pelvic floor rectum.The content was a brownish substance.The capsule was soft.It was preserved in formalin.There was no effect on the patient.[surgeon¿s comment] - the residual substance may have been surgicel, but it is not certain.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 is the lot number? was the reoperation related to the potential surgicel gauze found at the patient's pelvic floor? are there any pictures of the brownish mass found at the patient's pelvic floor 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.

Event Description

It was reported that a patient underwent an unknown obgyn procedure on an unknown date and absorbable hemostat was used.Absorbable hemostat used about six months ago was found in the pelvic floor as a brownish-brown mass during a re-operation.The surgeon said it is unknown if this individual is absorbable hemostat, but it is possible.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested, and the following was obtained: no allergies.No smoking or drinking habits.No pregnancy or menstruation at the time of adverse drug reaction 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? initial is as.47-year-old woman.166cm, 72kg.2.What are the name and date of index surgical procedure? on (b)(6) 2022, a laparotomy was performed due to recurrence of uterine fibroids.3.What were the diagnosis and indication for the index surgical procedure? recurrence of uterine fibroids.4.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 allergies.No smoking or drinking habits.No pregnancy or menstruation at the time of adverse drug reaction.5.Was there any intraoperative concurrent use of other products? in addition to surgicel, tachosil® and beriplast® were used.6.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? surgicel was used for minor intraoperative bleeding.7.Where was the surgicel used (on what tissue)? right cardinal ligament.8.What were current symptoms following the index surgical procedure? onset date? patient is in good condition.9.Has any surgical or medical intervention been performed? surgicel-like material was removed by re-operation.10.What is physician¿s opinion as to the etiology of or contributing factors to this event? residuals may be surgicel, but not sure.11.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative course? residuals may be surgicel, but not sure.12.What is the patient¿s current status? patient is in good condition.The following information was requested, but unavailable: 1.What is the lot number? 2.How much surgicel was used during the procedure? 3.What is the users experience w/ surgicel powder and other hemostatic agents? 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: a 1.Patient identifier, a 2.Patient age at the time of event, a 2.Age unit, a 3.Gender, a 4.Weight of the patient, a 4.Weight unit, b1 is adverse event, b2.Is other serious, h 6.Health effect - impact code additional information was requested, and the following was obtained: what is the lot number? the department that handles surgicel has been changed, so the lot number cannot be traced in this hospital.Was the reoperation related to the potential surgicel gauze found at the patient's pelvic floor? contrast-enhanced ct showed a mass in the lateral rectal space, and the patient underwent laparotomy to remove the foreign body.Are there any pictures of the brownish mass found at the patient's pelvic floor? yes the patient demographics] initial is as.47-year-old woman.166cm, 72kg.[progress] patient is in good condition.[health injury details] ct images showed a surgicel-like object remaining in the body, which was removed by laparotomy.[treatment details] on (b)(6) 2023, the patient underwent laparotomy to remove a foreign body, believed to be a surgicel [reason of the seriousness] patient impact is minor because the extraction has been completed.{product use details] original description : in (b)(6) 2022, the patient underwent open uterine myoma recurrence surgery.Recurrence : in (b)(6) 2023, the patient underwent re-surgery by laparotomy.Recurrence : in (b)(6) of the same year, the laparotomy was opened to resect the disseminated tumor.The tumor was examined and found to be a stamp.At that time, a 2.5 cm capsule-like object was found near the pelvic floor rectum.The content was a brownish substance.The capsule was soft.It was preserved in formalin.There was no effect on the patient.Correct description : in (b)(6) 2022, a laparotomy was performed due to recurrence of uterine fibroids.Because 3600 ml of bleeding occurred, surgicel gauze, tacoseal, and veriplast were used for hemostatic purposes to stop bleeding in the right basilar ligament.Seprafilm was used to prevent adhesion.On march 17, 4 months later, contrast tc showed a brown capsule-shaped mass 2 cm in size in the lateral rectal space, so the patient chose to have it removed by laparotomy.On may 15, the patient underwent excision of the pelvic mass.Disease name: smooth muscle tumor unknown malignant potential a 2.5 cm capsule-shaped object was found near the pelvic floor rectum.A dried clot was found in the lumen.Gross findings included fibrous material and infiltration of hemosiderin-poor histiocytes.The pathologist's findings were that it appeared to be an endometrioid cyst, but the above features could also be seen in the process of artifact absorption.The capsule is soft.It was preserved in formalin.On (b)(6) the mass was now removed and the patient recovered.Here is what the doctor heard from the patient.The patient underwent a total hysterectomy in (b)(6) 2022 at the (b)(6) clinic via a single hole speculum.During that procedure, a total of four morcellator teeth were broken when the uterus was being removed from the incision wound, and since the clinic did not have the teeth in stock, the wound may have been closed without removing the tumor.At the request of the clinic in question, a ct scan was performed in 2019.The ct scan was performed in (b)(6) 2023, what appeared to be a myoma was read in the location of the uterus that was supposed to have been removed.The shadow of what appeared to be a fibroid was also visible across the entire abdominal cavity, and the doctor commented that the doctor commented, "it is possible that the tumor was not completely removed during the initial surgery and has spread over the years." [surgeon¿s comment] residuals may be surgicel, but not sure.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 ORIGINAL 2INX3IN(5.1CMX7.6CM)
• 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: 16984647
• MDR Text Key: 315764889
• Report Number: 2210968-2023-03743
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031003033
• UDI-Public: 10705031003033
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/28/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1953
• Device Catalogue Number: 1953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 06/06/2023; 06/15/2023; 07/28/2023
• Supplement Dates FDA Received: 06/09/2023; 06/20/2023; 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 72 KG