MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 2-0 S/A SH CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J775D
Medical Device Problem Codes	Material Discolored (1170); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and a suture was used.It was reported that the patient visited the hospital for a checkup on december 19.Photograph of the vagina was taken.Images were taken that appeared to be slightly blue in color and with some sutures remaining.Thought to be a remnant of the suture used for ligation of the cardinal ligament or hemostasis.The patient was not notified because the patient had no complaint such as strange feeling.The surgeon informed sales rep just for information, and there is no particular request for additional action.No sample will be returned.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.The following information was requested, but was unavailable: lot number? no further information is available.No further information will be provided.What was the procedure date? no further information is available.Date the sutures remaining (slow absorption) was detected? no further information is available.No further information will be provided.The following additional information was received: additional info: the site of use: because bleeding was observed during surgery, it was used in the vagina as a hemostatic ligation.Was there only pigment remaining and the suture was absorbed? what was the color of the deposits? a pale blue color was seen, and no foreign matter was found.Treatment for hyperpigmentation: none.Current status of the patient: there was no problem with the patient.The patient probably will have a regular checkup 1 year later.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.

• Brand Name: VCL CT BRD VIO 8X18IN 2-0 S/A SH CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16146618
• Report Number: 2210968-2023-00297
• Device Sequence Number: 12462975
• Product Code: GAM
• UDI-Device Identifier: 10705031042933
• UDI-Public: 10705031042933
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2023

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: J775D
• Device Catalogue Number: J775D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 01/12/2023
• 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