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

Model Number CA500

Device Problem Failure to Fire (2610)

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

Event Date 12/05/2023

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: lap chole event description: the product was used in the lap cholecystectomy procedure.The clip applier missed fired 4 times after each other when clips were applied on the cystic duct & cystic artery when the lever was pulled to activate the clips, the clips did not move into the jaw of the clip applier, and missed fire 4 x times after each other.The surgeon constantly pulled the lever until the clips came out to complete the ligation of the clipping of the cystic duct & cystic artery.More clips were applied, and blood loss was minimal.Yes, the trigger could be moved as normal.I played with the clip applier after the case to see what the problem was but the miss firing only happened on the 2nd clip application.Yes, the clips did fully load into the jaws upon actuation.On the first attempt the 2nd attempt, 4 missed fires were noted after each other.The trigger was squeezed "plastic to plastic".Yes, the surgeon did skeletonize the vessel prior to using the clip applier.Dissector.The surgeon did not use the clip applier to skeletonize the tissue.Patient status: the patient is fine intervention: same clip applier.

Manufacturer Narrative

Applied medical has issued a voluntary recall of our epix universal clip applier for specific ca500 lots.These ca500 units are being recalled due to a nonconformance that may result in a clip not loading into the jaws after the trigger is actuated.Applied medical has recently implemented manufacturing corrections which are intended to reduce the potential for this type of incident to reoccur.The lot associated with this complaint, #(b)(4), was included in the recall.

Event Description

Procedure performed: lap chole.Event description: the product was used in the lap cholecystectomy procedure.The clip applier missed fired 4 times after each other when clips were applied on the cystic duct & cystic artery when the lever was pulled to activate the clips, the clips did not move into the jaw of the clip applier, and missed fire 4 x times after each other.The surgeon constantly pulled the lever until the clips came out to complete the ligation of the clipping of the cystic duct & cystic artery.More clips were applied, and blood loss was minimal.Yes, the trigger could be moved as normal.I played with the clip applier after the case to see what the problem was but the miss firing only happened on the 2nd clip application.Yes, the clips did fully load into the jaws upon actuation.On the first attempt the 2nd attempt, 4 missed fires were noted after each other.The trigger was squeezed "plastic to plastic".Yes, the surgeon did skeletonize the vessel prior to using the clip applier.Dissector.The surgeon did not use the clip applier to skeletonize the tissue.Patient status: the patient is fine.Intervention: same clip applier.

• 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 18422148
• MDR Text Key: 331684990
• Report Number: 2027111-2023-00887
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260511(30)01(10)1491914
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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: 1491914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2027111-01/26/24-001-R
• Patient Sequence Number: 1
• Treatment: CD001; LAP INSTRUMENTS