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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; CLIP, IMPLANTABLE
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APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; CLIP, IMPLANTABLE Back to Search Results
Model Number CA500
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Perforation of Vessels (2135)
Event Date 09/08/2020
Event Type  malfunction  
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: laparoscopic cholecystectomy.Rep was not present.Feedback provided post case by nurse.Rep will follow up with surgeon for further feedback and more details.Feedback stated that clips were not closing completely.Slight tear in tissue with application of clip as shown in image attached.Patient status is fine.Additional information received 17 sept 20: competitor device was used instead.Patient status: patient is unaffected.
 
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.However a photo of the event was provided by the complainant, which confirmed that the clips were not closing.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 based on the description of the event and the photo provided by the complainant.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible enhancements intended to further minimize the potential for this type of event to occur.
 
Event Description
Procedure performed: laparoscopic cholecystectomy.Rep was not present.Feedback provided post case by nurse.Rep will follow up with surgeon for further feedback and more details.Feedback stated that clips were not closing completely.Slight tear in tissue with application of clip as shown in image attached.Patient status is fine.Additional information received 17 sept 20: competitor device was used instead patient status: patient is unaffected.Intervention: competitor device was used instead.
 
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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 Key10590983
MDR Text Key208732523
Report Number2027111-2020-00568
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K011236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCA500
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/10/2020
Patient Sequence Number1
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