MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 48IN (122CM) 2-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number EH7779H

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2024

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 are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.* was there any change in the patient¿s post-operative care due to the prolonged procedure? attempts are being 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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.H6 component code: g07002 ¿ device not returned related events captured via: 2210968-2024-03394 2210968-2024-03395.

Event Description

It was reported that the patient underwent a hiatal hernia procedure on (b)(6) 2024, and suture was used.The surgeon wanted to use the device to tighten the pillars on a hiatal hernia, but every time she passed through the 5-balloon trocar, the needle pulled off 2 successive times.There was no patient consequence, but there was a delay in the procedure.Additional information was requested.

• Brand Name: PROLENE SUTURE 48IN (122CM) 2-0 BLU
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18967737
• MDR Text Key: 338988491
• Report Number: 2210968-2024-03394
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EH7779H
• Device Lot Number: RJBEHE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1