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

Model Number CA500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Injury (2348)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A follow up report will be sent once the results have been analyzed.

Event Description

Procedure performed: lap chol.On (b)(6) 2020, the material coordinator of the hospital called me that there has been a gal leakage by a patient that was operated on (b)(6) 2020.Because of this, the hospital stops with using the ca500.Because the leakage happened after the or (not known when) there is no clip applier to return and no lot number available.Patient status: gal leakage, no more information available.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation, and the lot number was not provided.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 unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.

Event Description

Procedure performed: lap chol (b)(6) 2020, the material coordinator of the hospital called me saying that there has been a gal leakage by a patient that was operated on 12 march 2020.Because of this, the hospital stopped using the ca500.Because the leakage happened after the or (not known when) there is no clip applier to return and no lot number is available.Patient status: gal leakage, no more information available type of intervention: ni.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIP, IMPANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9890539
• MDR Text Key: 187060471
• Report Number: 2027111-2020-00444
• Device Sequence Number: 1
• Product Code: FZP
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization