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

Model Number CA500

Device Problem Failure to Align (2522)

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

Event Date 07/11/2022

Event Type  malfunction  

Event Description

Procedure performed: laparoscopic gastrectomy event description: [user facility] the device was being used for laparoscopic gastrectomy.During laparoscopic operation, hemostasis did not work well because the clip was improperly closed (twisting) when the clip was fired.There was no health change.The case was completed with a new device.Product is available for return.Additional information was received via email on 14jul2022 from [name], ra/qa specialist applied medical korea.A grasper was also being used at the time of the event.The surgeon torqued the jaws on a vessel/tubular structure.The clip was not closed over thick/dense tissue.The jaws were not located completely around the vessel or structure to be ligated.The surgeon did not skeletonize the tissue with the jaws.Patient status: there was no patient injury.Intervention: the case was completed with a new device.

Manufacturer Narrative

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

Event Description

Procedure performed: laparoscopic gastrectomy event description: [user facility]: the device was being used for laparoscopic gastrectomy.During laparoscopic operation, hemostasis did not work well because the clip was improperly closed (twisting) when the clip was fired.There was no health change.The case was completed with a new device.Product is available for return.Additional information was received via email on 14jul2022 from [name], ra/qa specialist applied medical korea.A grasper was also being used at the time of the event.The surgeon torqued the jaws on a vessel/tubular structure.The clip was not closed over thick/dense tissue.The jaws were not located completely around the vessel or structure to be ligated.The surgeon did not skeletonize the tissue with the jaws.Patient status: there was no patient injury.Intervention: the case was completed with a new device.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as all clips closed properly when fired.The event unit met current specifications and there were no visible non-conformances.Based on the condition of the returned unit and the description of the event, it is likely that the cause of the reported event is use error.The instructions for use states, "do not twist or torque the clip applier jaws excessively when positioning or firing on a tubular structure or vessel.Excessive twisting or torquing may result in a malformed clip." the instructions for use also states, "locate the jaws completely around the vessel or structure to be ligated." the probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 15060123
• MDR Text Key: 304785026
• Report Number: 2027111-2022-00661
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)241024(30)01(10)1433949
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• 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: 101471777
• Device Lot Number: 1433949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2021
• 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