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 04/30/2021

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: lap chole.Device was put down applied medical 5mm trocar.Multiple clips scissored exact number is unknown.Replaced defective device with new ca500 and completed case.No injury to patient.The device is available for return.Additional information received via email on 05may2021 from [name]: the surgeon did skeletonize and use the clip applier appropriately.Additional information received via email on 14may2021 from [name] per [name], the surgical tech in the room at the time of the incident, yes the clip did deploy scissor over cystic duct and artery, clips were removed and replaced with different clips from a different applier.No photos were taken.Patient status: no patient injury.Type of intervention: replaced with a new ca500 and completed the case.

Event Description

Type of procedure: lap chole.Device was put down applied medical 5mm trocar.Multiple clips scissored exact number is unknown.Replaced defective device with new ca500 and completed case.No injury to patient.The device is available for return.Additional information received via email on 05may2021 from [name]: the surgeon did skeletonize and use the clip applier appropriately.Additional information received via email on 14may2021 from [name] per[name], the surgical tech in the room at the time of the incident, yes the clip did deploy scissor over cystic duct and artery, clips were removed and replaced with different clips from a different applier.No photos were taken.Patient status: no patient injury.Type of intervention: replaced with a new ca500 and completed the case.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.The returned unit was inspected and the feeder, 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 feeder, which could have occurred if the device was inserted/removed through the trocar with the feeder in the jaws.The instructions for use (ifu) states "do not place the clip applier through the trocar if a clip is present in the jaws.Doing so may result in damage to the device.".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: 11828505
• MDR Text Key: 250852803
• Report Number: 2027111-2021-00494
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)231103(30)01(10)1400110
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

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: 11/03/2023
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1400110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1