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

Model Number CA500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.

Event Description

Procedure performed: lap chole.Account manager was not present in any of the cases.The same surgeon for all 3 lap chole cases.1 occurred on nov 19 and 2 occurred on (b)(6), all were from the same lot number, 1326493.According to account manager, surgeon has used the applied clip applier extensively since it was re-introduced and hasn't experienced any issues until now.The same event description was given for all 3 events.While firing the clip onto the duct, the tip of the clip would not close.The trigger was squeezed plastic to plastic.They were able to finish the procedure with the same clip applier.Doesn't know if the clip was fully loaded into the jaws upon actuation.Doesn't know if the vessel was fully skeletonized prior to using the clip applier, but account manager said that he has been in many cases with surgeon and he has always skeletonized before using the clip applier in those prior cases.There was no harm to the patient.Devices were already discarded.Patient status: no harm to the patient.

Manufacturer Narrative

Investigation summary: the event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

Event Description

Procedure performed: lap chole.Account manager was not present in any of the cases.The same surgeon for all 3 lap chole cases.1 occurred on nov 19 and 2 occurred on nov 26, all were from the same lot number, 1326493.According to account manager, surgeon has used the applied clip applier extensively since it was re-introduced and hasn't experienced any issues until now.The same event description was given for all 3 events.While firing the clip onto the duct, the tip of the clip would not close.The trigger was squeezed plastic to plastic.They were able to finish the procedure with the same clip applier.Doesn't know if the clip was fully loaded into the jaws upon actuation.Doesn't know if the vessel was fully skeletonized prior to using the clip applier, but account manager said that he has been in many cases with surgeon and he has always skeletonized before using the clip applier in those prior cases.There was no harm to the patient.Devices were already discarded.Patient status: no harm to the patient.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: FZP
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8210841
• MDR Text Key: 131916861
• Report Number: 2027111-2019-00300
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)210520(30)01(10)1326493
• 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: 03/08/2019

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: 05/20/2021
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1326493
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 03/08/2019
• Patient Sequence Number: 1