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

Catalog Number	EZ10G
Medical Device Problem Codes	Break (1069); Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
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.H11 additional narrative: the following information was requested, but unavailable: are there photos of the packaging (with the holes visible) available for visual analysis? unk.Is it possible to confirm if the packaging was received with holes or if they occur during the event? unk.H3, h6 investigation summary: the product was returned to ethicon for evaluation.One suture outside the cannula in several fragments and one open foil packet that pertains to product code ez10g.During the visual inspection of the suture, it was noted that the suture has begun with degradation process attributed to exposure to the environment.This condition caused the suture to be broken in several pieces.The foil was visually inspected, and excessive wrinkles and holes in the cavity were 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 complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
Event or Problem Description
It was reported that the patient underwent a total laparoscopic hysterectomy on (b)(6) 2025 and suture was used.After opening the package, when the nurse took out the product from the package and handed over to the doctor, the suture broke at the root of the loop and the break point also broke along with the suture.When the sales rep confirmed the package, there were multiple holes in it, but it was not determined whether these had occurred when the doctor carried the product after the event occurred.Another device was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.

• 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: 22533031
• Report Number: 2210968-2025-08287
• Device Sequence Number: 12745706
• Product Code: NEW
• UDI-Device Identifier: 10705031206427
• UDI-Public: (01)10705031206427(17)250930(10)AN9038
• 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 Expiration Date: 09/30/2025
• Device Catalogue Number: EZ10G
• Device Lot Number: AN9038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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