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 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: cholecystectomy.Clips didn't hold in place when fired, they didn't close well.No other product involved.Additional information received by email from the sales rep on 6mar2019: 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.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 returned to applied medical for evaluation, along with a clip that was not completely closed.Visual inspection of the returned clip and testing of the event unit confirmed the reported event of incomplete clip closure.Based on the evaluation of the returned unit, applied medical 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 currently researching possible enhancements intended to further minimize the potential for this type of event to occur.

Event Description

Procedure performed: cholecystectomy.Clips didn't hold in place when fired, they didn't close well.No other product involved.Additional information received by email from the sales rep on 6mar19: 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.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: 8444730
• MDR Text Key: 139595788
• Report Number: 2027111-2019-00389
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)211216(30)01(10)1343871
• 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: 06/20/2019

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: 12/16/2021
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1343871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1