MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A3213, CLAMP (SIZE 5-60); CLAMP, VASCULAR

Model Number A3213

Device Problem Failure to Align (2522)

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

Event Date 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical for evaluation.A follow-up will be submitted upon completion of investigation.

Event Description

Procedure performed: aorta operation.Event description: tips of clamps are some how "tired" during operation tips were like crossed with inserts.It can cause problems to patient during operation.The user took another clamp.Clamp is still in hospital.I am waiting for instructions how to proceed with this issue.Additional information provided by applied medical representative via email 31dec21: product is able to be returned for evaluation.Yes, the surgeon did experience loss of occlusion due to jaw separation.No damage to the vessel.Device was resterilized before use.No rust noted on the device.No experience of insert detachment during use.Type of intervention: change of device.Patient status: patient is ok.

Manufacturer Narrative

The event unit has returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: aorta operation.Event description: tips of clamps are some how "tired" during operation tips were like crossed with inserts.It can cause problems to patient during operation.The user took another clamp.Clamp is still in hospital.I am waiting for instructions how to proceed with this issue.Additional information provided by applied medical representative via email 31dec21: product is able to be returned for evaluation.Yes, the surgeon did experience loss of occlusion due to jaw separation.No damage to the vessel.Device was resterilized before use.No rust noted on the device.No experience of insert detachment during use.Type of intervention: change of device.Patient status: patient is ok.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the unit, however, the complainant¿s experience of clamp malfunction could not be replicated.The returned unit did not exhibit any visual non-conformances.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: aorta operation.Event description: tips of clamps are some how "tired" during operation tips were like crossed with inserts.It can cause problems to patient during operation.The user took another clamp.Clamp is still in hospital.I am waiting for instructions how to proceed with this issue.Additional information provided by applied medical representative via email 31dec2021: product is able to be returned for evaluation.Yes, the surgeon did experience loss of occlusion due to jaw separation.No damage to the vessel.Device was resterilized before use.No rust noted on the device.No experience of insert detachment during use.Additional information received from applied medical representative via email on 4-may-2022: the hospital does not have any additional broken instruments.Type of intervention: change of device.Patient status: patient is ok.

• Brand Name: A3213, CLAMP (SIZE 5-60)
• 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: 13295906
• MDR Text Key: 285535817
• Report Number: 2027111-2022-00330
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607915112691
• UDI-Public: (01)00607915112691(11)210827(30)01(10)1421440
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K950492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2022

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
• Device Operator: Health Professional
• Device Model Number: A3213
• Device Catalogue Number: 100792801
• Device Lot Number: 1421440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 12/29/2021; 12/29/2021
• Supplement Dates FDA Received: 04/19/2022; 05/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1