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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 Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2021
Event Type  malfunction  
Manufacturer Narrative
The event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.
 
Event Description
Type of procedure performed: lap cholecystectomy.All clips scissored while putting them at the structures.Experienced surgeon who is working several years with this device so he knows how it works.Clipping mechanism seemed to work right.Took another ca500 and this device worked well.Serial number of this 2nd device is not known.No blood loss or other patient related problems because they saw it before cutting the structures.Patient status: no patient injury.Type of intervention: change of device.
 
Manufacturer Narrative
The event unit was returned to applied medical for evaluation.The complainant¿s experience could not be replicated as the returned unit was unable to load clips.However, the jaws were observed to be slightly misaligned, and the closure member was not welded properly.Based on the evaluation of the returned unit, the clips scissored due to the closure member that was not welded properly.No other affected units have been identified.
 
Event Description
Type of procedure performed: lap cholecystectomy.All clips scissored while putting them at the structures.Experienced surgeon who is working several years with this device so he knows how it works.Clipping mechanism seemed to work right.Took another ca500 and this device worked well.Serial number of this 2nd device is not known.No blood loss or other patient related problems because they saw it before cutting the structures.Patient status: no patient injury.Type of intervention: change ofd evice.
 
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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 Key11771117
MDR Text Key249022645
Report Number2027111-2021-00475
Device Sequence Number1
Product Code FZP
UDI-Device Identifier00607915125318
UDI-Public(01)00607915125318(17)240107(30)01(10)1406424
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 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/07/2024
Device Model NumberCA500
Device Catalogue Number101474072
Device Lot Number1406424
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2021
Was the Report Sent to FDA? No
Date Manufacturer Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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