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)
Type of Reportable Event	Malfunction
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 cannula and one suture outside the foil packet were received for analysis.Product code ez10g.During the visual inspection of the returned sample, no issues related to breakage suture were observed.However, it was noted that the suture was not tacked to the cannula.Since the suture was detached from the plug after the breakage of the score point.The product code ez10g contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no breakage suture was noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy on an unknown date, when the break point channel was broken, the suture broke.Since it was outside the body cavity, the doctor assumed that there was no problem and continued to use it, but the knot did not move to close the loop even when pressed the cannula, so the doctor decided it was a defective product and replaced it with a replacement.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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: 22110375
• Report Number: 2210968-2025-06022
• Device Sequence Number: 20870454
• Product Code: NEW
• UDI-Device Identifier: 10705031206427
• UDI-Public: (01)10705031206427(17)290430(10)AV4854
• 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: AV4854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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