MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J740D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4).H6 component code: g07002 - device not returned.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.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.The following information was requested, but unavailable: please provide lot number.=>unk.Events reported via: (b)(4).
Event or Problem Description
It was reported that a patient underwent a radical hysterectomy procedure on (b)(6) 2023 and suture was used.During the procedure, the suture was detached from the needle when pulling out the needle after passing the needle through the tissue.This issue occurred in 3 sutures in a row.They were control release needles.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 5/23/2023.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Related reports: 2210968-2023-02806, 2210968-2023-02807, and 2210968-2023-02808.

• Brand Name: VCL CT BRD VIO 8X18IN 0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 1000 route 202; raritan 08869
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16766147
• Report Number: 2210968-2023-02808
• Device Sequence Number: 20378916
• Product Code: GAM
• UDI-Device Identifier: 10705031042636
• UDI-Public: 10705031042636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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
• Operator of Device: Health Professional
• Device Model Number: J740D
• Device Catalogue Number: J740D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown