MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIG VICRYL VIO BR SUT; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number EJ10C

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 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.Additional information was requested, and the following was obtained via: how was the product purchased? is there an indication of how the product was distributed? is there any indication of the source? - these devices are original and officially imported to russia; they were directly sold to a qualified distributor medlink consumables llc (the confirming invoices in the attachment) based on the packaging, is there any indication of which market the original genuine product may have come from - these devices officially imported to russia.Please pay attention, only the russian-language labels added to the devices in russia are incorrect.Was the device used on a patient? if so, was there any patient consequence? - no information (the devices have already been sold in hospitals); device return status: the devices have already been sold, and the distributor refused to file a complaint.No patient consequence events reported via: 2210968-2022-05874, 2210968-2022-05875, 2210968-2022-05876, 2210968-2022-05877, 2210968-2022-05878, 2210968-2022-05880, 2210968-2022-05881 and 2210968-2022-05882.

Event Description

It was reported that a patient underwent an unknown procedure in 2022 and suture was used.Before use on the patient, it was reported that during shipment to the distributor of code ej10c according to upd no.(b)(4) and no.(b)(4) of 22.06.2022, an error was detected in the date of ru on the russian-language label (instead of 26.04 it is specified 27.04).No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 8/10/2022.H6 component code: g07002 no device returned.H6 component code: c22 - photo analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary ¿ photo analysis: this is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the photograph shows a section of a label.Image is not clear to determine failure mode or reported condition.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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.Events reported via: 2210968-2022-05874, 2210968-2022-05875, 2210968-2022-05876, 2210968-2022-05877, 2210968-2022-05878, 2210968-2022-05879, 2210968-2022-05880, 2210968-2022-05881 and 2210968-2022-05882.

• Brand Name: ENDOLOOP LIG VICRYL VIO BR SUT
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15100148
• MDR Text Key: 302080096
• Report Number: 2210968-2022-05879
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K925914
• 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
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EJ10C
• Device Lot Number: AR2831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1