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 Type  malfunction  

Event Description

Procedure performed: cholecystectomie.Event description: complaint 1 of 8: (b)(4), complaint 2 of 8: (b)(4), complaint 3 of 8: (b)(4), complaint 4 of 8: (b)(4), complaint 5 of 8: (b)(4), complaint 6 of 8: (b)(4), complaint 7 of 8: (b)(4), complaint 8 of 8: (b)(4).Translation: use on "cholecystectomy", placement of clips on cystic duct and cystic artery.The surgeons used the device as usual on several "cholecystectomies" performed in recent weeks, two surgeons (doctor [names redacted]) had similar problems with clips not coming out and some remaining partially open.Dr [name redacted] explained: "for several weeks, every 2 or 3 operations, the devices have not always delivered clips when the handle is fully engaged.In addition, some of the clips did not close completely and remained partially open.The clips moved slightly along the duct or artery.The surgeon reports that there was no impact on the patient.When the clip did not come out, the surgeon re-engaged the handle several times and the clips came out again.When the clip does not close completely, the surgeon secures it by applying an additional clip to the cystic duct and artery, as this problem does not occur with all clips from the same device, according to the surgeon.Additional information received from applied medical representative via email on 18dec23: the scrub call me back and say me that both surgeons (dr [name redacted] and dr [name redacted]) had a problem with the clip applier at least 4 times.The surgeons are sorry but they don¿t remember exactly how many time.Patient status: no impact on the patient.Intervention: continued using the device.Secured vessels with more than one clip.

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.

• 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: 18422073
• MDR Text Key: 331684245
• Report Number: 2027111-2023-00884
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260503(30)01(10)1490315
• 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
• Report Date: 12/29/2023

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: 1490315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2023
• Date Device Manufactured: 05/04/2023
• 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