MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES G-8650, 86MM INSERT S/F 15/BX; CLAMP, VASCULAR

Model Number	G-8650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that a base of the insert was broken, and the insert pad had been cut.Applied medical has reviewed the details surrounding the event and the returned unit and is unable to determine the root cause of the event based on the evaluation of the returned unit and description of the event.This a combined initial/final report.
Event or Problem Description
Type of procedure performed: cardiac surgery.Hospital: [name] "(b)(4).On (b)(6) 2021: during coronary artery bypass grafting during clamping the vessel, the surgeon replaced the insert in question to another new one because it was unusual.It was found the insert in question was broken after the surgery.The procedure was completed with no problem, and no adverse event occurred.The surgeon used the clamp manufactured by amr with the insert in question.The separated pad at damaged section was cut by the surgeon probably, however no further information provided from the hospital." comments from cosmotec: the hospital returned the complaint sample and will be returned to applied medical to investigate.Investigation report for this case is required as soon as possible.Type of intervention: replaced the insert in question to another new one.Patient status: no health damage was reported for the patient.

• Brand Name: G-8650, 86MM INSERT S/F 15/BX
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 12071678
• Report Number: 2027111-2021-00546
• Device Sequence Number: 19761360
• Product Code: DXC
• UDI-Device Identifier: 00607915111281
• UDI-Public: (01)00607915111281(17)250313(30)01(10)1381359
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K883790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2021

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: 03/13/2025
• Device Model Number: G-8650
• Device Catalogue Number: 100063401
• Device Lot Number: 1381359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1