MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES G-6150, 61MM INSERT S/F 15/BX; CLAMP, VASCULAR

Model Number	G-6150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: coronary artery bypass grafting event description: during a preparation for procedure, it was found the base part of insert was broken before use.The procedure was completed with no problem by using another g6150.The insert in question will be returned to you for the investigation.Product is available for return.Type of intervention: the procedure was completed with no problem by using another g6150.Patient status: no patient involvement.
Event or Problem Description
Procedure performed: coronary artery bypass grafting.Event description: during a preparation for procedure, it was found the base part of insert was broken before use.The procedure was completed with no problem by using another g6150.The insert in question will be returned to you for the investigation.Product is available for return.Type of intervention: the procedure was completed with no problem by using another g6150 patient status: no patient involvement.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the base of the insert was broken.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.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: G-6150, 61MM INSERT S/F 15/BX
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13943618
• Report Number: 2027111-2022-00531
• Device Sequence Number: 6431527
• Product Code: DXC
• UDI-Device Identifier: 00607915111267
• UDI-Public: (01)00607915111267(17)251215(30)01(10)1403976
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 12/15/2025
• Device Model Number: G-6150
• Device Catalogue Number: 100063201
• Device Lot Number: 1403976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown