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

Model Number CA500

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Type of procedure performed: lap chole.This clip applier was part of a lap chole kit 15 ref.#: (b)(4); lot number 1397741 a small black clip dislodged from the tip of the instrument whilst the clip applier was being fired.The clip was retrieved from the abdomen.This clip applier and part were removed from the surgical field.No harm was caused to the patient.The applier has not been decontaminate but held within the department for the company to view.This is ready for collection at caboolture clinical advisory teams office it is contaminated, however, this is inside original box and double bagged.Patient status: patient is fine, and completely unaffected.Type of intervention: ni.

Event Description

Type of procedure performed: lap chole this clip applier was part of a lap chole kit 15 ref gk308 lot number 1397741 a small black clip dislodged from the tip of the instrument whilst the clip applier was being fired.The clip was retrieved from the abdomen.This clip applier and part were removed from the surgical field.No harm was caused to the patient.The applier has not been decontaminate but held within the department for the company to view.This is ready for collection at caboolture clinical advisory teams office it is contaminated however this is inside original box and double bagged.Patient status: patient is fine, and completely unaffected type of intervention: ni.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the top housing, a partially exposed component located on the distal end of the shaft, had separated from the device.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the root cause of the reported event based on the evaluation of the returned unit and description of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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
• MDR Report Key: 11057675
• MDR Text Key: 223432720
• Report Number: 2027111-2020-00648
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)230511(30)01(10)1385468
• Combination Product (y/n): N
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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 Expiration Date: 05/11/2023
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1385468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1