MAUDE Adverse Event Report: ETHICON INC. VCL RAP UD 18IN 4-0 S/A P-3 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VR494
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown urological surgery on (b)(6) 2023 and suture was used.The suture was broken during use.Further details are not provided.No sample will be returned.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information: h6 component code: g07002 - device not received.Additional information has been requested and received.Quantity involved is 12.Could you please clarify how many devices had this issue (pull off suture needle)? please confirm quantity =>the suture was broken during use, but it was not sure how many sutures broke, though the sales rep reported it as 12.* could you please clarify if these are the lot numbers qjccrp, qdcccqeo? if yes, please provide quantity for each lot number =>yes, and quantity for each lot number is unk.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.The lots provided are invalid.Qjccrp, are there any more characters available? qdcccqeo, could the last character be a number 0? no product is available for return.Note: events reported on: mw# 2210968-2023-03197, mw# 2210968-2023-03198, mw# 2210968-2023-03199, mw# 2210968-2023-03200, mw# 2210968-2023-03201, mw# 2210968-2023-03202, mw# 2210968-2023-03203, mw# 2210968-2023-03204, mw# 2210968-2023-03205, 2210968-2023-03206, mw# 2210968-2023-03207, mw# 2210968-2023-03208.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/16/2023.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 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: mw# 2210968-2023-03197, mw# 2210968-2023-03198, mw# 2210968-2023-03199, mw# 2210968-2023-03200, mw# 2210968-2023-03201, mw# 2210968-2023-03202, mw# 2210968-2023-03203, mw# 2210968-2023-03204, mw# 2210968-2023-03205, 2210968-2023-03206, mw# 2210968-2023-03207, mw# 2210968-2023-03208.Product complaint # (b)(4).Date sent to the fda: 6/16/2023.Corrected information: h6 (b18 device discarded).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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/14/2023.Additional information was requested, the following was obtained: the lots provided are invalid: qjccrp, are there any more characters available?=>we only have information that the lot number as ""qjccrp"".Qdcccqeo, could the last character be a number 0? there is a possibility that the character is ""0"".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: mw# 2210968-2023-03197, mw# 2210968-2023-03198, mw# 2210968-2023-03199, mw# 2210968-2023-03200, mw# 2210968-2023-03201, mw# 2210968-2023-03202, mw# 2210968-2023-03203, mw# 2210968-2023-03204, mw# 2210968-2023-03205, mw# 2210968-2023-03207, mw# 2210968-2023-03208.

• Brand Name: VCL RAP UD 18IN 4-0 S/A P-3 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert- koch strass1; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16857037
• Report Number: 2210968-2023-03206
• Device Sequence Number: 8627154
• Product Code: GAM
• UDI-Device Identifier: 10705031134683
• UDI-Public: 10705031134683
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033746
• 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,Followup,Followup
• Report Date (Section B): 06/16/2023

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 Expiration Date: 09/01/2025
• Device Model Number: VR494
• Device Catalogue Number: VR494
• Device Lot Number: QDCCCQE0
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 05/26/2023; 06/16/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/14/2023; 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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