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

Model Number CA500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Blood Loss (2597)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Ra has received the event device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.

Event Description

Procedure performed: lapchole.None of the clips placed closed and they all fell into the patient.The clips were retrieved from the patient.Grabbed a larger clip, but ended up opening the patient to complete the case.The clip applier was used with the 5mm trocar.The trigger was squeezed "plastic to plastic".The surgeon fully skeletonized the vessel prior to using the clip applier.It is unknown if the clip was fully loaded into the jaws upon actuation.There was no patient injury.The device is available to be returned.Additional information received via email on 26nov2019 from account mgr they used an competitor 12mm clip applier.Why did dr open? "there were bleeding complications " was the bleeding r/t (related to) am clip applier? "clip kept falling off so i can¿t say 100% yes or no.We ended up opening an competitor applier and using it and still had to open to get control." patient status: no patient injury.

Event Description

Procedure performed: lapchole.None of the clips placed closed and they all fell into the patient.The clips were retrieved from the patient.Grabbed a larger clip, but ended up opening the patient to complete the case.The clip applier was used with the 5mm trocar.The trigger was squeezed "plastic to plastic".The surgeon fully skeletonized the vessel prior to using the clip applier.It is unknown if the clip was fully loaded into the jaws upon actuation.There was no patient injury.The device is available to be returned.Additional information received via email on 26nov2019 from account mgr they used an competitor 12mm clip applier.Why did dr open? "there were bleeding complications " was the bleeding r/t (related to) am clip applier? "clip kept falling off so i can¿t say 100% yes or no.We ended up opening an competitor applier and using it and still had to open to get control.".Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation with an excessive amount of dried blood in the shaft.Testing was unable to be performed on the event unit as the dried blood caused a jam in the event unit that prevented actuation.However, when clips were manually fed through the device, the clips closed properly.All components otherwise met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the root cause 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.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible enhancements intended to further minimize the potential for this type of event to occur.

• 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: 9497887
• MDR Text Key: 176782414
• Report Number: 2027111-2019-00672
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)220605(30)01(10)1359607
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1359607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention