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

Model Number CA500

Device Problem Migration (4003)

Patient Problem Exsanguination (1841)

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: laparoscopic cholecystectomy with intraoperative cholangiography event description: [translation] we experienced an issue with the epix clip applier on (b)(6) 2022, and would like to file an incident report.Patient condition: fairly abundant bloody effusion (500cc aspiration) after cholecystectomy.Corrective measures: installation of clips from another brand to clip again time of the event: placement of clips on the cystic artery without problem then section of the canal and the cystic artery.Realization of the cholecystectomy, then appearance of a bloody effusion: after aspiration there is no longer any clip on the cystic duct.These elements are included in the patient's operative report.[original] nous avons rencontré un problème avec la pince à clips epix le (b)(6), et nous souhaitons faire une déclaration d¿incident.Etat patient : épanchement sanglant assez abondant (aspiration de 500cc) après la cholécystectomie mesures correctives : pose de clips d¿une autre marque pour clipper à nouveau moment de l¿évènement : pose de clips sur l¿artère cystique sans problème puis section du canal et de l¿artère cystique.Réalisation de la cholécystectomie, puis apparition d¿un épanchement sanglant : après aspiration il n¿y a plus de clip sur le canal cystique.Ces éléments figurent dans le compte-rendu opératoire du patient.Vous remerciant par avance de revenir vers nous pour nous indiquer si vous avez connaissance de ce type de problème.Intervention: installation of clips from another brand to clip again.Patient status: fairly abundant bloody effusion (500cc aspiration) after cholecystectomy.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, a photo was provided, confirming the complainant's experience of clip slippage.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the clip slippage was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the clip slippage.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 performed: laparoscopic cholecystectomy with intraoperative cholangiography.Event description: translation: we experienced an issue with the epix clip applier on (b)(6) 2022, and would like to file an incident report.Patient condition: fairly abundant bloody effusion (500cc aspiration) after cholecystectomy.Corrective measures: installation of clips from another brand to clip again time of the event: placement of clips on the cystic artery without problem then section of the canal and the cystic artery.Realization of the cholecystectomy, then appearance of a bloody effusion: after aspiration there is no longer any clip on the cystic duct.These elements are included in the patient's operative report.Thanking you in advance for coming back to us to let us know if you are aware of this type of problem.Original: nous avons rencontré un problème avec la pince à clips epix le 25 janvier 2022, et nous souhaitons faire une déclaration d¿incident.Etat patient : épanchement sanglant assez abondant (aspiration de 500cc) après la cholécystectomie mesures correctives : pose de clips d¿une autre marque pour clipper à nouveau moment de l¿évènement : pose de clips sur l¿artère cystique sans problème puis section du canal et de l¿artère cystique.Réalisation de la cholécystectomie, puis apparition d¿un épanchement sanglant : après aspiration il n¿y a plus de clip sur le canal cystique.Ces éléments figurent dans le compte-rendu opératoire du patient.Vous remerciant par avance de revenir vers nous pour nous indiquer si vous avez connaissance de ce type de problème.Intervention: installation of clips from another brand to clip again.Patient status: fairly abundant bloody effusion (500cc aspiration) after cholecystectomy.

• 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: 13698497
• MDR Text Key: 296867265
• Report Number: 2027111-2022-00452
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)240629(30)01(10)1417521
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• 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: 1417521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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
• Patient Sex: Prefer Not To Disclose