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 No Consequences Or Impact To Patient (2199)

Event Date 02/18/2019

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: cholecystectomy.Date of occurrence: (b)(6) 2019.Description of the incident: malfunction of an epix ca 500 coelio clip applier = 1 clip out of 2 does not apply correctly, does not close well.Malfunction that occurred during the operative procedure.Event recurred (same operator) on (b)(6) 2019, same material different batch.Current state of the patient: none.Extension intervention: actions taken in the care facility for patient care: 1 of the 2 devices could be kept and sent to the supplier.Additional information received by email from the sales rep on 15apr19: the clip did fully load into the jaws upon actuation.The trigger was squeezed "plastic to plastic".The surgeon did fully skeletonize the vessel prior to using the clip applier.The surgeon did not use the clip applier to skeletonize tissue.Question: what end of the clip (apex or tip) did not close? response: every part closed but not completely so the clips didn¿t hold.Patient status: ok.

Manufacturer Narrative

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: cholecystectomy.Date of occurrence: (b)(6) 2019.Description of the incident: malfunction of an epix ca 500 coelio clip applier = 1 clip out of 2 does not apply correctly, does not close well.Malfunction that occurred during the operative procedure.Event recurred (same operator) on 27/02/2019, same material different batch.Current state of the patient: none.Extension intervention actions taken in the care facility for patient care: 1 of the 2 devices could be kept and sent to the supplier.Additional information received by email from the sales rep on 15apr19: the clip did fully load into the jaws upon actuation.The trigger was squeezed "plastic to plastic".The surgeon did fully skeletonize the vessel prior to using the clip applier.The surgeon did not use the clip applier to skeletonize tissue.Question: what end of the clip (apex or tip) did not close? response: every part closed but not completely so the clips didn¿t hold.Patient status: ok.

• 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: 8592127
• MDR Text Key: 145796356
• Report Number: 2027111-2019-00443
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)211210(30)01(10)1343463
• 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: 06/21/2019

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: 12/10/2021
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1343463
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 06/21/2019
• Patient Sequence Number: 1