MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CTX; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A400

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2022

Event Type  malfunction  

Event Description

It was reported from health authority a patient underwent a myomectomy on (b)(6) 2022 and suture was used.During the surgery, doctors used suture to sew the residual end of the uterus.The suture broke when it just entered the abdomen.Changed another one to complete the surgery.No additional information could be provided.

Manufacturer Narrative

(b)(4).Additional information has been requested and the following however not received.If further details are received at a later date a supplemental medwatch will be sent.Was there any adverse consequence associated with the patient? lot reported: samdor is not a valid lot.Please verify lot? no product is available for return.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 g/m.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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 h 6.Health effect - clinical code, h 6.Health effect - impact code.Additional information was requested, and the following was obtained: after investigation, a 45-year-old female patient underwent myomectomy on (b)(6) 2022 (with specific surgical methods unknown).The operator used the sxpp1a400 for suturing the fibroid wound in a continuous sewing manner.The suture broke after entering the abdominal cavity during the operation.The operator immediately replaced a new sxpp1a400 device (with specific product batch number unknown) for suturing.The subsequent operation went smoothly.This event led to prolonged operation time (with specific delay time unknown) and increased blood loss (with specific increase volume of blood loss unknown).The patient recovered well currently and was discharged smoothly.No subsequent adverse event report was received.After contacting with the hospital, the hospital did not provide the correct lot number of the product.The specific lot number of the product involved was unknown.The following information was requested, but unavailable: was there any adverse consequence associated with the patient? lot reported: samdor is not a valid lot.Please verify lot? this report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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 has been requested and the following was received.If further details are received at a later date a supplemental medwatch will be sent.Contact with the sales via phone today, no further information available for below questions.Was there any adverse consequence associated with the patient? lot reported: samdor is not a valid lot.Please verify lot? this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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: SFX SYM PDS+ UNI VIO 18IN 1 S/A CTX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125,; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16126465
• MDR Text Key: 308569918
• Report Number: 2210968-2023-00208
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219366
• UDI-Public: 10705031219366
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A400
• Device Catalogue Number: SXPP1A400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 01/11/2023; 01/29/2023
• Supplement Dates FDA Received: 01/27/2023; 01/31/2023
• 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 Age: 45 YR
• Patient Sex: Female