MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 9IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number SXPP1B455

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  malfunction  

Event Description

It was reported that the patient underwent a robotic assisted epigastric hernia repair procedure on (b)(6) 2024 and barbed suture was used.The suture broke while suturing unknown tissue with the robotic arm.Another unknown suture was used to continue with the procedure.There were no adverse consequences for the patient.No further information was provided.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6.Component code: g07002: device not returned.

• Brand Name: SFX SPI PDS+ UNI VIO 9IN 0 S/A CT-1
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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: 18980763
• MDR Text Key: 338762603
• Report Number: 2210968-2024-03468
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031240834
• UDI-Public: 10705031240834
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1B455
• Device Lot Number: TABERH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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