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 07/27/2022

Event Type  malfunction  

Event Description

Type of procedure: laparoscopic cholecystectomy.Event description: the event occurred when pulling the trigger and clips were crossing over.When trigger applied, clips were crossing over themselves instead of meeting at the points.No details given as to changes in health.Have requested replacement or credit.No details given as to other instruments used.Additional information received via email from [name] on 28 july 2022: no injury.Yes and applied medical trocar was used.Additional information was received via email from [name] on 15 august 2022: the problem was when the device was fired, no clip came out on multiple occasions.Attempts to load a new clip were inconsistent.In regards to the specific questions: no torque, the structure was not thick, it was skeletonized.I resolved the situation by using a different clip applier.Patient status: details of patient status not provided as of yet.Intervention: not known.

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

Type of procedure: laparoscopic cholecystectomy event description: the event occurred when pulling the trigger and clips were crossing over when trigger applied, clips were crossing over themselves instead of meeting at the points.No details given as to changes in health.Have requested replacement or credit.No details given as to other instruments used.Additional information received via email from [name] on 28 july 2022: no injury.Yes and applied medical trocar was used.Additional information was received via email from [name] on 15 august 2022: the problem was when the device was fired, no clip came out on multiple occasions.Attempts to load a new clip were inconsistent.In regards to the specific questions: no torque, the structure was not thick, it was skeletonized.I resolved the situation by using a different clip applier.Patient status: no injury.Intervention: i resolved the situation by using a different clip applier.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection noted a clip in the jaw and a damaged feeder, a component involved in loading clips.Functional testing could not be performed on the returned unit as it was jammed.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by damage to the feeder.The damaged feeder was likely caused by the unit being passed through the trocar with the feeder in the jaws.The probability and criticality of 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: 15287978
• MDR Text Key: 302285978
• Report Number: 2027111-2022-00714
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)250320(30)01(10)1447205
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1447205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• 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