MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; CLIP, IMPLANTABLE

Model Number CA500

Device Problems Failure to Align (2522); Failure to Fire (2610)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: unk.Event description: surgeon said it will cut the tissue instead of clipping it.Used it two times same action and discarded.[name] stated the following gin her initial email for this report dated 6 september 2021: i have asked for more detail but they are unable to provide any.Intervention: used it two times same action and discarded.Patient status: case was completed.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.However, the complainant¿s experience of cut tissue could not be replicated as the returned device was jammed.The jaws of the returned unit were observed to be misaligned.Based on the condition of the returned unit, it is possible that the reported event was caused by the misaligned jaws, which could cause the clips to scissor.However, the root cause of the misaligned jaws could not be determined based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: unk event description: surgeon said it will cut the tissue instead of clipping it.Used it two times same action and discarded.Intervention: used it two times, same action and discarded patient status: case was completed.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIP, IMPLANTABLE
• 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: 12471739
• MDR Text Key: 271457127
• Report Number: 2027111-2021-00625
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)240325(30)01(10)1413454
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2024
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1413454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female