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 06/07/2022

Event Type  malfunction  

Event Description

Procedure performed: lap cholecystectomy.Event description: i was on this clinic this morning with my manager to follow up with a surgeon who had a cer few weeks ago.We first did a lap hysterectomy, the surgeon used our clip applier to secure the hemostasis during the procedure and everything went good.Then, we did a lap cholecystectomy using our clip applier.After having properly skeletonized the cytic duct and the cystic artery, the surgeon introduced the clip applier through a 5mm kii trocar (ctf03) and placed a clip on the cystic duct.The clip was not closed properly.The surgeon took it out and placed another one which immediately crossed.We observed that the clips derailed from the jaws of the applier and did not ensure a good closure, nor a good placement of the clip in the desired position.He took the clip applier out and ask for another one.The damaged clip applier and the two clips are available at the pharmacy for being returned and further investigation.Please find attached pictures of the jaws where we can see that the flat piece of metal inside if the jaws is folded/damaged.The surgeon squeezed the handle plastic-to-plastic, no clip over another.The surgeon placed the clip applier aside and ask for another one.With the new clip applier ca500 same lot number, he performed the procedure without any trouble.The surgeon had a grasper left hand to hold on the gallbladder and used the clip applier right hand.Intervention: change of device.Patient status: ok.

Manufacturer Narrative

The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the evaluation.

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 scissored 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.This damage 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.

Event Description

Procedure performed: lap cholecystectomy.Event description: pictures available in attachments.I was on this clinic this morning with my manager to follow up with a surgeon who had a cer few weeks ago.We first did a lap hysterectomy, the surgeon used our clip applier to secure the hemostasis during the procedure and everything went good.Then, we did a lap cholecystectomy using our clip applier.After having properly skeletonized the cytic duct and the cystic artery, the surgeon introduced the clip applier through a 5mm kii trocar (ctf03) and placed a clip on the cystic duct.The clip was not closed properly.The surgeon took it out and placed another one which immediately crossed.We observed that the clips derailed from the jaws of the applier and did not ensure a good closure, nor a good placement of the clip in the desired position.He took the clip applier out and ask for another one.The damaged clip applier and the two clips are available at the pharmacy for being returned and further investigation.Please find attached pictures of the jaws where we can see that the flat piece of metal inside if the jaws is folded/damaged.The surgeon squeezed the handle plastic-to-plastic, no clip over another.The surgeon placed the clip applier aside and ask for another one.With the new clip applier ca500 same lot number, he performed the procedure without any trouble.The surgeon had a grasper left hand to hold on the gallbladder and used the clip applier right hand.Intervention: change of device patient status: ok.

• 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 (Section G): 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: 14734949
• MDR Text Key: 294290524
• Report Number: 2027111-2022-00635
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)240830(30)01(10)1417542
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• 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: 1417542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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
• Treatment: CTF03