MAUDE Adverse Event Report: ETHICON INC. PDS*II VLT 0 45CM - ENDOLOOP; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	EZ10G03
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) h6 component code: g07002 - device evaluation pending.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 device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested, and the following was obtained via: please confirm if the holes were seen in the device, sterile packaging (sealed) or box packaging.If other, please provide additional details.It was seen when checking for sterility.Are there photos available for visual analysis? mismatch information: expected ez10g03 lot# av2059 but instead we received (1) ez10g03; lot# av2059 and (1) ez10g03; lot# av6483.Product received under awb# (b)(4); from (b)(6) the ro-1225723 has been created for the ez10g03; lot# av6483 so that cg labs can ship it to the analysis site.Please confirm if the additional lot# av6483 belongs to this complaint.Updating: three additional samples have been received in relation to this complaint.The product was received under awb# (b)(4) on september 9, 2025.Received (3) ez10g lot# av9078, lot# au5456, and lot# aw2655.Please confirm if these lot#s are also associated with this complaint.Yes, same complaint for all the products.No ¿ customer sent it in.Please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager) material manager.
Event or Problem Description
It was reported that a patient underwent a trauma procedure in 2025 and suture was used.Before use on the patient, it was reported to the dl per sales rep, they were complaining of wholes being in the product.No adverse impact patient/user.Device is available for return.There were no adverse consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (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.Additional information: h6, h3, d4, d9 corrected data: d4 full udi was incorrectly reported in initial.H3 investigation summary: the product was returned to ethicon for evaluation.One unopened sample was received for analysis.Product code ez10g, lot av2059.During the visual inspection of the foil packet, it was noted excessive wrinkles.The packet was opened and holes in cavity could be observed.The condition of the package is indicative of handling and storage issues that occurred outside of ethicon control.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device evaluation pending 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 information: h6, d9 the device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Common Device Name: 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 paulo 12240 ; BR 12240
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23145136
• Report Number: 2210968-2025-11005
• Device Sequence Number: 18621081
• Product Code: GEA
• UDI-Device Identifier: 10705031206427
• UDI-Public: (01)10705031206427(17)281231(10)AV2059
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K843187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2025

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 Catalogue Number: EZ10G03
• Device Lot Number: AV2059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 10/17/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 10/08/2025; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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