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

Model Number CA500

Device Problem Failure to Align (2522)

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

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: "[institution] informed me of an incident today.Surgery was today with ca500.I will have more information tomorrow when i visit the account." additional information was received via email on 14sep2023 from [name], account manager iv, applied medical.It is unknown what was being sealed/clipped at the time of the event.The surgeon pulled the trigger plastic to plastic and no clip was delivered.Then the clips to follow the first activation began to scissor.The case was completed with a competitive clip applier.No known injury.Product is available for return.Patient status: no known injury.Intervention: the case was completed with a competitive clip applier.

Manufacturer Narrative

The event unit returned to applied medical for evaluation.Functional testing was performed on the event unit.The complainant¿s experience of clips scissoring could not be replicated or confirmed as the unit passed relevant functional testing and no visible non-conformances were observed.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event 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: laparoscopic cholecystectomy.Event description: "[institution] informed me of an incident today.Surgery was today with ca500.I will have more information tomorrow when i visit the account.".Additional information was received via email on 14sep2023 from [name], account manager iv, applied medical.It is unknown what was being sealed/clipped at the time of the event.The surgeon pulled the trigger plastic to plastic and no clip was delivered.Then the clips to follow the first activation began to scissor.The case was completed with a competitive clip applier.No known injury.Product is available for return.Patient status: no known injury.Intervention: the case was completed with a competitive clip applier.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIPS, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17835861
• MDR Text Key: 324501372
• Report Number: 2027111-2023-00609
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260613(30)01(10)1495834
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1495834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• 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
• Treatment: GRASPER; SCOPE