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

Model Number G-6150

Device Problem Break (1069)

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

Event Date 03/11/2022

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 288361476
• Report Number: 2027111-2022-00531
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607915111267
• UDI-Public: (01)00607915111267(17)251215(30)01(10)1403976
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K883790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1