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

Model Number CA500

Device Problem Use of Device Problem (1670)

Patient Problem Perforation of Vessels (2135)

Event Date 11/07/2019

Event Type  malfunction  

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: lap chole.Surgeon was given clip applier and inserted into the abdomen.The surgeon did not pre-load the first clip, instead fully squished over the vessel in a one step deployment and nicked the artery.There was minimal bleeding from the artery.The artery was not completely lacerated.Tried to place another clip and no clip loaded or came out of the clip applier.Pressure was applied utilizing a grasper until a clip could be placed and bleeding suctioned for visualization.Removed the clip applier from the patient and tried to fire over the mayo several time until it started working.Put the clip applier back in the patient and continued the case.The applied 5x100mm trocar was used with the clip applier.This was the first clip and there were no known issues prior to trying to deploy a clip for ligation.The trigger was squeezed plastic-to-plastic.The jaws were not torqued and there was minimal to zero tension applied.Device is available to be returned.Additional information was received from account manager, via e-mail on november 18th, 2019: "the surgeon can¿t confirm that a clip did actually fully load.He did state that the clip didn¿t appear to be in the jaws upon ligating, and may have fallen out.Due to blood around the vessel and the extra clips added quickly in effort to achieve hemostasis, he is unsure." patient status: no patient injury.

Manufacturer Narrative

Investigation summary: the event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However the complainant¿s experience could not be replicated or confirmed.The event unit met current specifications and there were no visible non-conformances.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by the user¿s clip application technique.The instructions for use (ifu), states "prior to ligating, inspect the device to ensure that the clip is fully advanced in the jaws.Prior to locating the jaws around the vessel or structure, partially close the clip applier trigger to load clips in the jaws.Verify the clip has been properly positioned in the jaws.".

Event Description

Procedure performed: lap chole.Surgeon was given clip applier and inserted into the abdomen.The surgeon did not pre-load the first clip, instead fully squished over the vessel in a one step deployment and nicked the artery.There was minimal bleeding from the artery.The artery was not completely lacerated.Tried to place another clip and no clip loaded or came out of the clip applier.Pressure was applied utilizing a grasper until a clip could be placed and bleeding suctioned for visualization.Removed the clip applier from the patient and tried to fire over the mayo several time until it started working.Put the clip applier back in the patient and continued the case.The applied 5x100mm trocar was used with the clip applier.This was the first clip and there were no known issues prior to trying to deploy a clip for ligation.The trigger was squeezed plastic-to-plastic.The jaws were not torqued and there was minimal to zero tension applied.Device is available to be returned.Additional information was received from account manager, via e-mail on (b)(6) 2019 "the surgeon can¿t confirm that a clip did actually fully load.He did state that the clip didn¿t appear to be in the jaws upon ligating, and may have fallen out.Due to blood around the vessel and the extra clips added quickly in effort to achieve hemostasis, he is unsure." patient status: no patient injury.

• 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: 9432392
• MDR Text Key: 177760388
• Report Number: 2027111-2019-00649
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)220602(30)01(10)1359605
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2022
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1359605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1