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: ni event description: complaint 1 of 2: (b)(4) complaint 2 of 2: (b)(4) good morning, i see that the 5mm clippers are recalled.I didn¿t realize this until now.I don¿t see the attachment to fill out.Are you able to forward it to me? also, we just had a 5mm clipper malfunction and its not on the lot number list below.Ours is lot #1496522 and lot #1501035.Please let me know if i can send these in for evaluation.Additional information provided by [name] on 9apr2024 via email: i tracked down the surg tech that did the case and it was from march 6, the clips wouldn¿t advance to use during case.They had to open both clippers ¿ same thing happened.After the second failure, the dr.Requested to use an ethicon stapler.After that patient went to recovery and haven¿t heard anything that the patient needed any other care.I still have them if you want me to send them back to you, otherwise i will put in sharps container.Yes, they were both used in this case that day.Patient status: no patient injury intervention: ni.

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: 19159691
• MDR Text Key: 341475227
• Report Number: 2027111-2024-00599
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260713(30)01(10)1496522
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2024

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 Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1496522
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 07/14/2023
• 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