MAUDE Adverse Event Report: ETHICON, LLC COATED VICRYL; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	J947H
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Suture needle pulls off like a pop-off needle should.This should not happen with this type of suture.The surgeon requested this to be documented and reported as this had also happened in the past.

• Brand Name: COATED VICRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, LLC; 475 c street; los frailes industrial park, s; guaynabo PR 00969
• MDR Report Key: 20609598
• Report Number: 20609598
• Device Sequence Number: 7928638
• Product Code: GAM
• UDI-Device Identifier: 10705031043688
• UDI-Public: (01)10705031043688
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2024
• Report Date (Section F): 09/12/2024

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 Model Number: J947H
• Device Catalogue Number: J947H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Date Report Sent to FDA: 09/12/2024