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 Insufficient Information (4580)

Event Date 09/16/2021

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: when the clip fired onto tissue the clip 1426401 had misaligned.On further deployment of the clip, they were also misaligned.Clips are not straight.  additional information received via email from [name] on 29sep2021: the customer has come back to us advising they can not discuss patient status due to privacy but has confirmed that yes the clips were scissored.No other information can be ascertained.Intervention: ni.Patient status: ni.

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: when the clip fired onto tissue the clip 1426401 had misaligned.On further deployment of the clip, they were also misaligned.Clips are not straight.Additional information received via email from [name] on 29sep21: the customer has come back to us advising they can not discuss patient status due to privacy but has confirmed that yes the clips were scissored.No other information can be ascertained.Intervention: ni.Patient status: ni.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the complainant¿s experience of misaligned clips.Visual inspection noted that the channel support assembly (csa), a metal component in the shaft, was damaged.Based on the evaluation of the returned unit, it is likely that the reported event was caused by the damaged csa, which likely resulted from the component being caught within the jaws and was damaged when the device was inserted through the trocar or actuation of the trigger.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: 12587101
• MDR Text Key: 281102224
• Report Number: 2027111-2021-00660
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)240516(30)01(10)1417805
• 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: 12/17/2021

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 Expiration Date: 05/16/2024
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1417805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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