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 Type  malfunction  

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 cholecystectomy.Event description: rep was not present for the case.During the procedure the clips scissored.The surgeon did not torque the jaws on a vessel or tubular structure.The rep does not believe that the clip closed over thick/dense tissue.It is unknown if the jaws were located completely around the vessel or structure to be ligated.The surgeon did not skeletonize tissue with the jaws.There was no patient injury.The case was completed with another ca500.Product available for return.Additional information was received via email on 01apr2022 from [name], applied medical account manager i: "the clip did scissor [.] when ligating the cystic duct." intervention: the case was completed with another ca500.Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, where all clips fired and closed properly.Therefore, the complainant¿s experience could not be replicated as the event unit passed functional testing and there were no visible non-conformances.Based on the condition of the returned unit and the event description, the root cause of the reported event could not be determined.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: laparoscopic cholecystectomy.Event description: rep was not present for the case.During the procedure the clips scissored.The surgeon did not torque the jaws on a vessel or tubular structure.The rep does not believe that the clip closed over thick/dense tissue.It is unknown if the jaws were located completely around the vessel or structure to be ligated.The surgeon did not skeletonize tissue with the jaws.There was no patient injury.The case was completed with another ca500.Product available for return.Additional information was received via email on 01apr2022 from [name], applied medical account manager i "the clip did scissor [.] when ligating the cystic duct." intervention: the case was completed with another ca500.Patient status: no patient injury.

• 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: 14138264
• MDR Text Key: 291484896
• Report Number: 2027111-2022-00559
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)240505(30)01(10)1417451
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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: 101474072
• Device Lot Number: 1417451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1