MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIG W/PDS II; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	EZ10G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a laparoscopic appendectomy for appendicitis on (b)(6) 2025 and suture was used.During use on the patient, when folded the break point and pulled the cannula, the suture came loose, so it could not be pulled the cannula.The device was about to be used on the radix of appendix.Another device was used to complete the case.There were no adverse consequences to the patient.One device will be returning.No further information is available.
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.H3 investigation summary = > the product was returned to ethicon for evaluation.One open foil with a suture inside cannula that pertains to product code ez10.To assess the condition of the returned sample, the suture was removed from the cannula.Upon examination, no issues related to suture breakage were observed.However, it was noted that the suture was not attached to the cannula.The detachment appeared to have occurred after the score point broke.Additionally, the loop was partially closed and twisted.Although no conclusion could be reached on the cause of the reported event.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: ENDOLOOP LIG W/PDS II
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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: 22867019
• Report Number: 2210968-2025-09649
• Device Sequence Number: 18481455
• Product Code: NEW
• UDI-Device Identifier: 10705031206427
• UDI-Public: (01)10705031206427(17)291231(10)AW2656
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331/S027
• 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

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: EZ10G
• Device Lot Number: AW2656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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