MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC SURGIPOINT; SUTURE

Model Number	LV-493B
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
The device was not returned.The reporter could not identify the lot number for the product but indicated that it was one of two possible lot numbers (lot 20082511; 20113003).Retains from both lot numbers provided were tested for finished goods testing, including needle attachment and tensile strength testing.All samples tested passed.A cause of the event could not be established and the report could not be substantiated.If additional information is provided to riverpoint medical llc regarding this event, a supplementary 3500a form will be submitted as required by the fda.
Event or Problem Description
According to the reporter, "the needle separated from the thread.The doctor disposed of the defective suture.".

• Brand Name: SURGIPOINT
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 12044751
• Report Number: 3006981798-2021-00006
• Device Sequence Number: 11707805
• Product Code: GAM
• UDI-Device Identifier: 00812444020250
• UDI-Public: 00812444020250
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

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: 07/31/2025
• Device Model Number: LV-493B
• Device Lot Number: 20082511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1